History of Changes for Study: NCT05130268

Version	Submitted Date	Changes
1	November 10, 2021	None (earliest Version on record)
2	November 29, 2021	Arms and Interventions and Study Status
3	March 16, 2022	Recruitment Status, Study Status, Contacts/Locations and Study Identification
4	April 1, 2022	Study Status and Contacts/Locations
5	April 8, 2022	Contacts/Locations and Study Status
6	May 20, 2022	Study Status and Contacts/Locations
7	May 27, 2022	Contacts/Locations and Study Status
8	June 3, 2022	Study Status and Contacts/Locations
9	June 14, 2022	Contacts/Locations and Study Status
10	June 17, 2022	Contacts/Locations and Study Status
11	July 5, 2022	Study Status and Contacts/Locations
12	July 19, 2022	Contacts/Locations and Study Status
13	August 5, 2022	Study Status and Contacts/Locations
14	August 11, 2022	Contacts/Locations and Study Status
15	August 23, 2022	Contacts/Locations and Study Status
16	August 29, 2022	Contacts/Locations and Study Status
17	September 7, 2022	Study Status and Contacts/Locations
18	September 16, 2022	Contacts/Locations and Study Status
19	October 14, 2022	Study Status and Contacts/Locations
20	October 20, 2022	Contacts/Locations and Study Status
21	November 10, 2022	Study Status and Contacts/Locations
22	November 16, 2022	Contacts/Locations and Study Status
23	November 22, 2022	Contacts/Locations and Study Status
24	December 7, 2022	Eligibility and Study Status
25	December 9, 2022	Contacts/Locations and Study Status
26	December 16, 2022	Contacts/Locations and Study Status
27	February 6, 2023	Contacts/Locations and Study Status
28	February 27, 2023	Contacts/Locations and Study Status
29	March 8, 2023	Study Status and Contacts/Locations
30	March 9, 2023	Contacts/Locations and Study Status
31	March 10, 2023	Contacts/Locations and Study Status
32	March 27, 2023	Contacts/Locations and Study Status
33	March 28, 2023	Contacts/Locations and Study Status
34	March 30, 2023	Contacts/Locations and Study Status
35	April 5, 2023	Study Status and Contacts/Locations
36	May 9, 2023	Study Status and Contacts/Locations
37	May 12, 2023	Contacts/Locations and Study Status
38	May 17, 2023	Contacts/Locations and Study Status
39	May 24, 2023	Contacts/Locations and Study Status
40	May 30, 2023	Contacts/Locations and Study Status
41	June 6, 2023	Study Status and Contacts/Locations
42	June 21, 2023	Contacts/Locations and Study Status
43	June 27, 2023	Contacts/Locations and Study Status
44	July 5, 2023	Study Status and Contacts/Locations
45	July 11, 2023	Contacts/Locations and Study Status
46	July 18, 2023	Contacts/Locations and Study Status
47	July 24, 2023	Eligibility and Study Status
48	July 28, 2023	Eligibility and Study Status
49	July 31, 2023	Contacts/Locations and Study Status
50	August 3, 2023	Study Status and Contacts/Locations
51	August 9, 2023	Contacts/Locations and Study Status
52	August 11, 2023	Contacts/Locations and Study Status
53	August 15, 2023	Contacts/Locations and Study Status
54	August 18, 2023	Contacts/Locations and Study Status
55	August 24, 2023	Contacts/Locations and Study Status
56	August 28, 2023	Contacts/Locations and Study Status
57	September 1, 2023	Study Status and Contacts/Locations
58	September 8, 2023	Contacts/Locations and Study Status
59	September 15, 2023	Contacts/Locations and Study Status
60	September 20, 2023	Contacts/Locations and Study Status
61	October 3, 2023	Study Status and Contacts/Locations
62	November 29, 2023	Recruitment Status, Study Status and Contacts/Locations

Brief Summary:

While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected AF. In usual care, these patients are started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker) along with stroke prevention therapy. The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved cardiovascular outcomes and quality of life in patients first-detected AF.

The purpose of this study is to determine if treatment with dronedarone on top of usual care is superior to usual care alone for the prevention of cardiovascular hospitalization or death from any cause in patients hospitalized with first-detected AF. All patients will be treated with guideline-recommended stroke prevention therapy according to the CHA2DS2-VASc score. The treatment follow-up period will be 12 months. There will be two follow-up visits. Consistent with the pragmatic nature of the trial, the first follow-up will occur between 3 -9 months and the 2nd will occur at 12 months (with a window of +/- 30 days). Approximately 3000 patients will be enrolled and randomly assigned (1:1) to study intervention. The study intervention will be dronedarone 400 mg twice daily in addition to usual care versus usual care alone.

Detailed Description:

Atrial fibrillation (AF) is the most common sustained arrhythmia encountered in clinical practice, accounting for one-third of arrhythmia-related hospitalizations.1 As many as 1 in 4 people develop AF over their lifetime after the age of 40 years. The prevalence and burden of AF in the United States is substantial; the age-adjusted incidence and prevalence has increased over the last 3 decades. Moreover, the number of Americans with AF is expected to increase 150% by 2050. The goals of care in the treatment of AF include (1) the management and reduction of risk factors, (2) prevention of tachycardia (rate control), (3) prevention of stroke, and (4) improvement of symptoms. Reduction or elimination of symptoms often requires rhythm control. Historically, randomized clinical trials have not demonstrated a mortality or stroke benefit with a rhythm control versus a rate control strategy.

Despite the failure of prior randomized clinical trials to demonstrate the superiority of rhythm control, the recent Early Treatment of Atrial Fibrillation for Stroke Prevention 4 (EAST-AFNET 4) trial demonstrated that early introduction of a comprehensive rhythm-control strategy (within one year of diagnosis) is superior to guideline-based usual care in improving cardiovascular (CV) outcomes at a mean follow-up of 5 years. The EAST-AFNET 4 trial found that early rhythm control reduced the primary outcome of CV death, stroke, hospitalization for heart failure (HF), or acute coronary syndrome (HR 0.79, 96% confidence interval (CI) 0.66-0.94, p = 0.005). EAST-AFNET 4 also demonstrated a reduction in the risk of stroke with early introduction of rhythm control (HR 0.65, 95% CI 0.44-0.98), a finding that was also observed with dronedarone in the ATHENA trial. In addition, maintenance of sinus rhythm has been associated with improved quality of life and increased exercise capacity in some patients. Outside of clinical trials, a quality-of-life study from the Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RECORD-AF) found that rhythm control was associated with better quality of life.

There are several antiarrhythmic drugs (AADs) available for rhythm control of AF. Class I antiarrhythmic agents are predominantly limited to younger patients without coronary artery or structural heart disease. Patients with advanced chronic kidney disease, prolonged QT intervals, and/or severe left ventricular hypertrophy should not be treated with sotalol or dofetilide. Even when sotalol or dofetilide can be used, patients are often hesitant to start a medication that requires an inpatient hospitalization for drug loading and laboratory evaluation every 3 months. Amiodarone has been shown to be the most effective AAD for maintaining sinus rhythm in patients with AF; however, based on its side effect profile, amiodarone is only recommended as a first-line agent under specific clinical circumstances. Moreover, despite its efficacy, amiodarone has high rates of discontinuation due to frequent adverse events. In addition to its unfavorable side effects, several studies, including those of patients at risk for sudden cardiac death, have demonstrated an association between amiodarone use and higher mortality, as well as lower functional status. In contrast to amiodarone, dronedarone is a much better tolerated antiarrhythmic medication. In randomized controlled trials, dronedarone has been shown to prevent recurrent AF, improve rate control, and decrease cardiovascular hospitalization in patients with AF.

While there are several completed clinical trials that address treatment strategy in patients with symptomatic and recurrent AF, there are no randomized clinical trials that address treatment for first-detected or new-onset AF. After appropriate evaluation for oral anticoagulation, these patients are often started on an atrioventricular nodal blocking agent (beta-blocker or non-dihydropyridine calcium channel blocker). The investigators hypothesize that earlier administration of a well-tolerated antiarrhythmic drug proven to reduce hospitalization may result in improved quality of life and cardiovascular outcomes in patients with first-detected AF.

Risk Assessment:

Dronedarone is approved by the Food and Drug Administration to reduce the risk of hospitalization for AF in patients with paroxysmal or persistent AF. The efficacy and safety of dronedarone 400 mg twice daily was evaluated in five controlled studies, ATHENA, ANDROMEDA, European Trial in Atrial Fibrillation or Flutter Patients Receiving Dronedarone for the Maintenance of Sinus Rhythm (EURIDIS), ADONIS, and Dronedarone Atrial FibrillatioN study after Electrical Cardioversion (DAFNE), involving more than 6,000 patients with including more than 3200 patients who received dronedarone. As with any therapeutic agent, there are known risks with dronedarone therapy. These risks include hepatic injury, heart failure exacerbation, increased exposure to digoxin, increased plasma concentration of tacrolimus, sirolimus, and other Cytochrome P450, family 3, subfamily A (CYP 3A) substrates, and very rare instances of pulmonary toxicity. The risks of dronedarone are felt to be outweighed by its benefits. The guideline recommendations provided by the European Society of Cardiology and American Heart Association (AHA)/American College of Cardiology (ACC)/Heart Rhythm Society (HRS) are commensurate with this risk benefit assessment.

Benefit Assessment:

While there are no completed randomized clinical trials to guide selection or initiation of rhythm control therapies in patients with first-detected AF, there are recent trials that suggest benefit with both dronedarone antiarrhythmic therapy and early-initiation of rhythm control in persons with AF. the recent EAST-AFNET 4 trial demonstrated that early introduction of a comprehensive rhythm-control strategy (within one year of diagnosis) is superior to usual guideline-recommended care in improving cardiovascular (CV) outcomes at 5 years. The median time from new-onset AF to randomization in the EAST-AFNET4 trial was 36 days. The trial found that early rhythm control reduced the primary outcome of CV death, stroke, hospitalization for HF, or acute coronary syndrome (HR 0.79, 95% confidence interval 0.66-0.94, p = 0.005). EAST-AFNET 4 also demonstrated a reduction in the risk of stroke with early introduction of rhythm control (HR 0.65, 95% CI 0.44-0.98), a finding that was also observed with dronedarone in the ATHENA trial. Thus, the investigators hypothesize that early initiation of dronedarone in patients with new-onset AF will lead to a reduction in CV hospitalization or death.

Overall Design:

Dronedarone is approved by the Food and Drug Administration to reduce the risk of CV hospitalization in patients with AF or atrial flutter. However, it is unknown if dronedarone (or any antiarrhythmic medication) can reduce CV hospitalization or death in patients with first-detected AF. This trial has been designed to address this important question. In order to facilitate the trial enrollment, data collection, and a generalizability to clinical practice, the CHANGE AFIB study has been designed as an open-label pragmatic clinical trial nested within the Get With The Guidelines (GWTG) Atrial Fibrillation registry. At present the overall GWTG program is being implemented in over 2,300 hospitals across the U.S. and is comprised of over 9 million patient records, with an estimated 650,000 new patient records entered per year. The trial will utilize the existing GWTG registry network, data collection architecture, and experience to facilitate both enrollment and conduct of the trial.

The comparator arm will be "usual care." Thus, this study will compare usual care plus dronedarone versus usual care alone. In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the USPI when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

CHANGE AFIB will leverage several critical advantages as a pragmatic clinical trial. Data collection will be integrated into the Get With The Guidelines AFIB registry. The use of the GWTG-AFIB registry will also enhance subject recruitment and ensure the enrollment of a diverse group of patients. The randomized intervention will be compared with usual care thus further enhancing generalizability. Follow-up visits will be minimized to reduce patient burden. Moreover, follow-up visits will have "windows" to accommodate variation in follow-up intervals at different centers.

Justification for Study Drug Intervention and Dose:

Dronedarone is a non-iodinated benzofuran similar to amiodarone but is not associated with thyroid or pulmonary toxicity in randomized clinical trials or post-marketing observational studies. Dronedarone has electrophysiological characteristics spanning all 4 Vaughan-Williams anti-arrhythmic classes, with primarily class III effects. Initial trials suggested that dronedarone prolonged the time to recurrence of AF and reduced cardiovascular death and hospitalization.

The landmark ATHENA trial evaluated the efficacy and safety of dronedarone in patients with atrial arrhythmias (atrial fibrillation or atrial flutter). This trial did not include patients with a recent history of New York Heart Association (NYHA) class IV heart failure or recent hospitalization for decompensated heart failure (<4 weeks). Approximately, 30% of the ATHENA population had NYHA class I-III heart failure. ATHENA demonstrated that dronedarone 400 mg twice daily (in combination with background therapy) reduced the combined endpoint of CV hospitalization or death from any cause by 24% (p<0.001) compared with placebo. Of course, the ATHENA trial was not conducted in the special population of patients with a new diagnosis of AF. There are no randomized trials or guideline recommendations for antiarrhythmic therapy at the time of first-detected AF. A subgroup analysis from the ATHENA trial suggests that optimal outcomes may be achieved in those patients with shorter duration of AF (time from diagnosis). Similar observations have also been made in patients undergoing other forms of rhythm control, including catheter ablation. In this trial, patients with first-detected AF will be randomized to dronedarone on top of usual care versus usual care alone. Patients randomized to the intervention arm will be prescribed and treated with Dronedarone 400 mg bid. This dose has been chosen as it is the Food and Drug Administration approved dose as well as the dose recommended in current international guidelines. Dronedarone has also been shown to be an effective rate control agent as well. In the ERATO study treatment with dronedarone 400 mg twice daily let to a mean reduction of 24.5 beat/min in patients with permanent AF when compared with placebo. In the EURIDIS/ADONIS studies the mean difference in patients with paroxysmal/persistent AF during AF recurrence was 14 beats/min. Moreover, the dronedarone treated patients experienced improved rate control without any reduction in exercise tolerance as measured by maximal exercise.

Arms

Assigned Interventions

Experimental: Dronedarone

In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. As dronedarone has anti-adrenergic rate controlling properties, a low dose of beta-blocker or calcium-channel blocker is recommended in the United States Prescribing Information (USPI) when starting dronedarone. In the dronedarone arm concomitant digoxin use will be contraindicated due to P-gp interaction based upon data from the PALLAS trial. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

Drug: Dronedarone

Dronedarone 400 mg twice daily in addition to usual care

Other Names:

Multaq

No Intervention: Usual care

In most patients, the investigators anticipate usual care to include an atrioventricular nodal blocking agent (beta-blocker, non-dihydropyridine calcium channel blocker, or digoxin) without an antiarrhythmic. All patients will receive oral anticoagulation for stroke prevention according to current guideline recommendations.

Primary Outcome Measures:

Cardiovascular Hospitalization or Death
[ Time Frame: Evaluated through 12 months from randomization ]

First occurrence of unplanned CV hospitalization or death from any cause within 12 months of randomization. All unplanned hospitalizations (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) for cardiovascular causes will be considered a cardiovascular hospitalization.

Secondary Outcome Measures:

Win Ratio
[ Time Frame: Evaluated through 12 months from randomization ]

Among the randomized patients, every patient in the dronedarone arm will be compared with every patient in the usual care arm. Within each pair of patients, the component outcomes will be compared in descending order of importance until one of the patients in the pair demonstrates a better outcome compared with the other. For the purpose of this trial the hierarchy of component outcomes are shown below. The components in the WIN ratio hierarchy are similar to the endpoints considered in the recent EAST AFNET4 trial.

Hierarchy of Outcomes for the WIN Ratio:

All-cause mortality
Ischemic stroke or systemic embolism
Hospitalization for new/worsening diagnosis of heart failure
Hospitalization for acute coronary syndrome

All-cause mortality
[ Time Frame: Evaluated through 12 months from randomization ]

For descriptive purposes, deaths will be categorized by the site investigators according to the following categories: cardiovascular and non-cardiovascular. Cardiovascular deaths will be further classified into arrhythmic vs non-arrhythmic according the modified Hinkle-Thaler criteria, as used in several landmark cardiovascular trials. Patients who are well and (1) have a witnessed sudden collapse or (2) those found dead, but known to be alive and well in the previous 24 hours (e.g. no signs or symptoms of cardiorespiratory distress) will be defined as having arrhythmic death.

Ischemic stroke or systemic embolism
[ Time Frame: Evaluated through 12 months from randomization ]

The occurrence of ischemic stroke will be defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction. Symptoms or signs must persist ≥24 hours, unless the stroke is documented by CT, MRI or autopsy, in which case the duration of symptoms/signs may be less than 24 hours. Stroke may be classified as ischemic (including hemorrhagic transformation of ischemic stroke), hemorrhagic, or undetermined. Systemic embolism will be defined as acute arterial insufficiency or occlusion of the extremities or any non-CNS organ associated with clinical, imaging, surgical/autopsy evidence of arterial occlusion in the absence of other likely mechanism (e.g., trauma, atherosclerosis, or instrumentation).

Hospitalization for new/worsening diagnosis of heart failure
[ Time Frame: Evaluated through 12 months from randomization ]

Hospitalization for new or worsening heart failure will be defined as any unplanned hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to a new diagnosis or worsening symptomatic heart failure

Hospitalization for acute coronary syndrome
[ Time Frame: Evaluated through 12 months from randomization ]

Any hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to acute coronary syndrome.

Time to first unplanned cardiovascular hospitalization
[ Time Frame: Evaluated through 12 months from randomization ]

Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The key secondary endpoint will be time to first unplanned CV hospitalization (similar to the component of the primary endpoint).

Unplanned cardiovascular hospitalizations--secondary analysis using Anderson-Gill extension
[ Time Frame: Evaluated through 12 months from randomization ]

Given the importance of CV hospitalization as an outcome from a clinical perspective, patient perspective, and economic perspective, there will be two analyses of CV hospitalization. The second exploratory analysis of unplanned cardiovascular hospitalization will use a method to account for repeated events (Anderson-Gill extension).

Other Outcome Measures:

Any unplanned arrhythmia-related hospitalization
[ Time Frame: Evaluated through 12 months from randomization ]

Arrhythmia-Related Hospitalization will be defined as any unplanned hospitalization (i.e. admission with an overnight stay in an acute care healthcare facility/hospital) due to any tachy or brady-arrhythmia.

Number of participants who experience AF progression
[ Time Frame: Evaluated through 12 months from randomization ]

AF Progression will be defined as the transition from (a) paroxysmal to persistent or (b) persistent to permanent AF.

Number of participants who undergo cardioversion (pharmacologic or electrical)
[ Time Frame: Evaluated through 12 months from randomization ]

Cardioversion (either pharmacologic or electrical) with or without transesophageal echocardiographic guidance will be a tertiary endpoint.

Number of participants who have ablation of AF (catheter, surgical or hybrid) performed
[ Time Frame: Evaluated through 12 months from randomization ]

Ablation of AF including catheter ablation, surgical ablation, or hybrid (endocardial and epicardial ablation) ablation will be a tertiary endpoint.

Days alive and outside of the hospital
[ Time Frame: Evaluated through 12 months from randomization ]

Days Alive and Out of the Hospital. Days alive and out of the hospital (DAOH, also referred to as "home time") is an emerging clinical trial endpoint that is both pragmatic and patient centered. It is highly correlated with traditional time-to-event mortality and hospitalization outcomes.

Patient-Reported Quality of Life--AFEQT
[ Time Frame: At baseline and 12 months ]

The AFEQT is a 21-item, AF-specific health-related QOL questionnaire that assesses the impact of AF on patient-reported quality of life. The AFEQT includes a summary score (calculated from 18 of the questions) and subscale scores in three domains: symptoms, daily activities, and treatment concern. The summary and subscale scores range from 0 (corresponds to complete AF-related disability) to 100 (no AF-related disability). A change of 5 or more points in the AFEQT has been identified as a benchmark for a clinically meaningful difference in an individual patient.

Patient-Reported Quality of Life--MAFSI
[ Time Frame: At baseline and 12 months ]

The MAFSI was developed as a modification and update of the AF Symptom Checklist. The trial will use a modified MAFSI questionnaire comprised of a 10-item AF symptom checklist that asks about frequency and severity of each symptom. Frequency of symptoms is recorded as 0 (never), 1 (rarely), 2 (sometimes), 3 (often), or 4 (always). These responses are summed for a total Frequency Score that ranges from 0 (no AF symptoms) to 40 (worst score). MAFSI Severity Scores are recorded as 1 (mild), 2 (moderate), or 3 (extreme). Severity scores are summed and range from 0 (no AF symptoms) to 30 (most severe AF symptoms). A clinically meaningful change in the MAFSI has not previously been established and therefore will be considered to be about ¼ of the pooled baseline standard deviation (SD), or 1.6 points for the Frequency Score and 1.3 points for the Severity Score.

Minimum Age:

21 Years

Maximum Age:

Sex:

All

Gender Based:

Accepts Healthy Volunteers:

Criteria:

Inclusion Criteria:

Age >=21 years.
First-detected atrial fibrillation (defined as atrial fibrillation diagnosed in the previous 120 days).
Electrocardiographic documentation of atrial fibrillation.
Estimated life expectancy of at least 1 year.
Patient or legal authorized representative capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria:

1. Patients with prior or planned treatment with rhythm control, either catheter ablation or chronic (>7 days) antiarrhythmic drug therapy.

3. Planned cardiothoracic surgery. 4. New York Heart Association class III or IV heart failure or a hospitalization for heart failure in the last 4 weeks.

5. Patients with reduced ejection fraction (LVEF ≤40%). 6. Permanent atrial fibrillation. 7. Ineligible for oral anticoagulation, unless CHA2DS2-VASc is less than 3 in women or 2 in men.

8. Bradycardia with a resting heart rate < 50 bpm 9. PR interval >280 msec or 2nd degree or 3rd degree atrioventricular block without a permanent pacemaker/cardiac implanted electronic device.

10. Corrected QT interval >=500 msec. 11. Pregnancy or breast feeding. 12. Severe hepatic impairment in the opinion of the investigator.

Central Contact Person:

Samantha Johnson, MPH
Telephone: +1 (609) 223-3730
Email: ChangeAFib@heart.org

Central Contact Backup:

Susana Almeida-Peters, BN, RN
Telephone: +1 (919) TBD-0000
Email: ChangeAF@duke.edu

Study Officials:

Jonathan P Piccini, MD, MHS
Principal Investigator
Duke Clinical Research Organization

Locations:

United States, Arizona

Mercy Gilbert Medical Center
[Recruiting]
Gilbert, Arizona, United States, 85297
Contact:Contact: Kate Eastman, RN kate.eastman@dignityhealth.org
Contact:Principal Investigator: Rachel M. Bond, MD

United States, California

Los Angeles Medical Center (Kaiser Permenente)
[Recruiting]
Los Angeles, California, United States, 90027
Contact:Contact: Dalia Salazar dalia.x.salazar@kp.org
Contact:Principal Investigator: Nigel Gupta, MD

West Los Angeles Medical Center
[Recruiting]
Los Angeles, California, United States, 90034
Contact:Contact: Dalia Salazar Dalia.X.Salazar@kp.org
Contact:Principal Investigator: Nigel Gupta, MD

Cedars Sinai Medical Center
[Recruiting]
Los Angeles, California, United States, 90048
Contact:Contact: Goran Stankovic 310-423-1620 goran.stankovic@cshs.org
Contact:Principal Investigator: Christine M Albert, MD

UC Irvine Medical Center (AKA UCI Health)
[Recruiting]
Orange, California, United States, 92868
Contact:Contact: Emily Bernal bernale2@hs.uci.edu
Contact:Principal Investigator: Michael Rochon-Duck, MD

Los Robles Health System - Los Robles Regional Medical Center
[Recruiting]
Thousand Oaks, California, United States, 91360
Contact:Contact: Marya Bengali marya.bengali@hcahealthcare.com
Contact:Principal Investigator: Andrea Natale, MD, FHRS, FACC, FESC

UCLA Medical Center - Harbor
[Recruiting]
Torrance, California, United States, 90502
Contact:Contact: Sajad Hamal, MS, CCRP 310-974-9336 shamal@lundquist.org
Contact:Principal Investigator: Houman Khakpour, MD

United States, Colorado

Colorado Heart & Vascular Group - St. Anthony's Hospital
[Recruiting]
Lakewood, Colorado, United States, 80228
Contact:Contact: David E Bailey, BS 303-595-2619 dbailey@chvpc.com
Contact:Principal Investigator: Ganesh Venkataraman, MD

Colorado Heart & Vascular Group - St. Anthony's North Health Campus
[Recruiting]
Westminster, Colorado, United States, 80023
Contact:Contact: David Bailey, BS 303-595-2619 dbailey@chvpc.com
Contact:Principal Investigator: Ganesh Venkataraman, MD

United States, Delaware

Christiana Hospital
[Recruiting]
Newark, Delaware, United States, 19718
Contact:Contact: Annamarie Henry, RN, BSN annhenry@christianacare.org
Contact:Principal Investigator: David Kim, MD

United States, Florida

Life Spring Research Foundation, LLC
[Recruiting]
Miami, Florida, United States, 33130
Contact:Contact: Yvette Rodriguez yrodriguez@lifespringresearch.com
Contact:Principal Investigator: Hector S. Rodriguez, MD

Nouvelle Clinical Research LLC
[Recruiting]
Miami, Florida, United States, 33130
Contact:Contact: Nilda Cespedes ncespedes@nouvelleclinicalresearch.com
Contact:Principal Investigator: Elie R. Haddad, MD

Golden Touch Clinical Research
[Recruiting]
Miami, Florida, United States, 33144
Contact:Contact: Yurien Cedeno, RN ycedeno@gtouchresearch.com
Contact:Principal Investigator: Giralt Yanez, MD

Excellence Medical And Research, LLC
[Recruiting]
Miami, Florida, United States, 33169
Contact:Contact: Isis Gonzalez igonzalez@emrclinic.com
Contact:Principal Investigator: Jeremy Bleicher, DO MPH

Ocean Wellness Center, LLC
[Recruiting]
Miami Gardens, Florida, United States, 33169
Contact:Contact: Denis Ruiz druiz@owcclinic.com
Contact:Principal Investigator: Jeremy Bleicher, DO MPH

The Angel Medical Research
[Recruiting]
Miami Lakes, Florida, United States, 33156
Contact:Contact: Angel Achong achong@theangelresearch.com
Contact:Principal Investigator: John Dylewski, MD FACC FHRS

Northside Hospital
[Recruiting]
Saint Petersburg, Florida, United States, 33709
Contact:Contact: Michelle Nelson, LPN Michelle.Nelson@hcahealthcare.com
Contact:Principal Investigator: Robert Sheppard, MD

Guardian Angel Research Center
[Recruiting]
Tampa, Florida, United States, 33614
Contact:Contact: Gabriela Morales data2@garesearch.org
Contact:Principal Investigator: Liuber Carballar Alberteries, MD

United States, Georgia

Northeast Georgia Medical Center
[Recruiting]
Gainesville, Georgia, United States, 30501
Contact:Contact: Donna Patrick, RN donna.patrick@nghs.com
Contact:Principal Investigator: Joon Ahn, MD

Georgia Arrhythmia Consultants and Research Institute
[Recruiting]
Macon, Georgia, United States, 31201
Contact:Contact: Semisola Oludare soludare@gacri.com
Contact:Principal Investigator: Felix O. Sogade, MD FACC FHRS

Wellstar Kennestone Hospital
[Recruiting]
Marietta, Georgia, United States, 30062
Contact:Contact: Deborah Bell, BS 470-793-4066 deborah.bell@wellstar.org
Contact:Principal Investigator: Michael J Riley, MC, FACC

United States, Illinois

Mt Sinai Hospital Medical Center
[Recruiting]
Chicago, Illinois, United States, 60608
Contact:Contact: Toma Peic Tukuljac toma.tukuljac@prismsgrp.com
Contact:Principal Investigator: Sandeep Khosla, MD FACC FACP FCCP FSCAI

Rush University Medical Center
[Recruiting]
Chicago, Illinois, United States, 60612
Contact:Contact: Jamil Rahman jamil_rahman@rush.edu
Contact:Principal Investigator: Timothy R. Larsen, DO FACC FHRS

University of Illinois Hospital
[Recruiting]
Chicago, Illinois, United States, 60612
Contact:Contact: Yining Chen yining@uic.edu
Contact:Principal Investigator: David Tofovic, MD

Riverside Medical Center
[Recruiting]
Kankakee, Illinois, United States, 60901
Contact:Contact: Cynthia Koehn, MSN, RN 815-931-9763 ckoehn@rhc.net
Contact:Contact: Tiffany Furlan, BSN 815-933-1671 tfurlan@rhc.net
Contact:Principal Investigator: Abhimanyu Beri, MD

Loyola University Medical Center
[Recruiting]
Maywood, Illinois, United States, 60153
Contact:Contact: Jean Del Priore, RN jdelpri@luc.edu
Contact:Principal Investigator: Menhel Kinno, MD MPH

Captain James A Lovell Federal Health Care Center
[Recruiting]
North Chicago, Illinois, United States, 60064
Contact:Contact: Teresa L Toleda, MSN, RN 224-610-1310 Teresa.todela@va.gov
Contact:Contact: Kyle B Hines, BSN, RN 224-610-1307 Kyle.Hines@va.gov
Contact:Principal Investigator: Raul J Gazmuri, MD PhD FCCM

Proctor Community Hospital
[Recruiting]
Peoria, Illinois, United States, 61614
Contact:Contact: Savannah Cranford, BS, CCRC 309-672-3118 savannah.cranford@unitypoint.org
Contact:Contact: Sidney M Woll 309-672-3153 Sidney.Woll@unitypoint.org
Contact:Principal Investigator: Alexander Adler, MD

Methodist Medical Center of Illinois
[Recruiting]
Peoria, Illinois, United States, 61636
Contact:Contact: Savannah J Cranford, BS, CCRC 309-672-3118 Savannah.Cranford@unitypoint.org
Contact:Contact: Sidney Woll (309) 672-3153 sidney.woll@unitypoint.org
Contact:Principal Investigator: Alexander Adler, MD

Trinity Rock Island
[Recruiting]
Rock Island, Illinois, United States, 61201
Contact:Contact: Shaina Wagner, RN shainaw@cvmedpc.com
Contact:Principal Investigator: Mark J. Shen, MD, FHRS

St. Elizabeth's Hospital of the Hospital Sisters of the Third Order of St. Francis
[Recruiting]
Springfield, Illinois, United States, 62769
Contact:Contact: Lauren Bainter, RT(R) CCRC 217-492-9115 lbainter@prairieresearch.com
Contact:Principal Investigator: Mark Shen, MD

St. John's Hospital of the Hospital Sisters of the Third Order of St. Francis
[Recruiting]
Springfield, Illinois, United States, 62769
Contact:Contact: Lauren Bainter, RT(R) CCRC 217-492-9115 lbainter@prairieresearch.com
Contact:Principal Investigator: Mark Shen, MD

Carle Foundation Hospital
[Recruiting]
Urbana, Illinois, United States, 61801
Contact:Contact: Carly Skadden, MPH, CCRP 217-904-7276 caly.skadden@carle.com
Contact:Principal Investigator: Mbu Mongwa, MD

United States, Indiana

Parkview Hospital, Inc.
[Recruiting]
Fort Wayne, Indiana, United States, 46845
Contact:Contact: Matthew Pyron, RN (260)266-5656 matthew.pyron@parkview.com
Contact:Principal Investigator: Roy Robertson, MD, FACC, FSCAI

Ascension St Vincent Hospital - Indianapolis
[Recruiting]
Indianapolis, Indiana, United States, 46260
Contact:Contact: Allyn Harker, RN allyn.harker@ascension.org
Contact:Principal Investigator: Parin J. Patel, MD FACC FHRS

United States, Kansas

Kansas City Heart and Vascular Specialists at Providence Medical Center
[Recruiting]
Kansas City, Kansas, United States, 66112
Contact:Contact: Emily Ostrander, MSN APRN FNP NP-C Eostrander@primehealthcare.com
Contact:Principal Investigator: Prasanth S. Katrapati, MD FACC FSCAI RPVI

Overland Park Regional Medical Center
[Recruiting]
Overland Park, Kansas, United States, 66215
Contact:Contact: Kimberly Kosbab, LPN kimberly.kosbab@hcahealthcare.com
Contact:Principal Investigator: Rajesh Kabra, MD FHRS FACC

United States, Kentucky

Baptist Health Lexington
[Recruiting]
Lexington, Kentucky, United States, 40223
Contact:Contact: Kait Nolan, RN 859-260-4484 katie.nolan@bhsi.com
Contact:Principal Investigator: Gery Tomassoni, MD, FACC

Saint Joseph Hospital
[Recruiting]
Lexington, Kentucky, United States, 40504
Contact:Contact: Tracie Carl-Nagel, RN, BSN, CCRC 859-313-4459 tracienagel@sjhlex.org
Contact:Principal Investigator: Yousef H Darrat, MD

United States, Louisiana

Heart Clinic of Hammond
[Recruiting]
Hammond, Louisiana, United States, 70403
Contact:Contact: Issa Jordan ibr-ajl@rocketmail.com
Contact:Principal Investigator: Ghiath M. Mikdadi, MD FACC FSCAI

Tulane Medical Center
[Recruiting]
New Orleans, Louisiana, United States, 70112
Contact:Contact: Suzanne Bowers, RN sbowers@tulane.edu
Contact:Principal Investigator: Anand Irimpen, MD

United States, Maryland

Luminis Health Anne Arundel Medical Center
[Recruiting]
Annapolis, Maryland, United States, 21401
Contact:Contact: Kathleen W Gray, RN 443-481-5868 kgray7@luminishealth.org
Contact:Principal Investigator: Sean Beinart, MD

Adventist Healthcare Shady Grove Medical Center
[Recruiting]
Rockville, Maryland, United States, 20850
Contact:Contact: Meseret Y Deressa, MD, MPH 240-826-6167 MDeressa1@adventisthealthcare.com
Contact:Contact: Shilpa Rele 240-826-6167 srele@adventisthealthcare.com
Contact:Principal Investigator: Omar Shams, MD

United States, Massachusetts

Brigham and Womens Hospital
[Recruiting]
Boston, Massachusetts, United States, 02115
Contact:Contact: Christine Pellegrini, RN, MSN/MHSA 617-732-5241 cpellegrini@bwh.harvard.edu
Contact:Principal Investigator: Sunil Kapur, MD

United States, Michigan

McLaren Bay Region
[Recruiting]
Bay City, Michigan, United States, 48708
Contact:Contact: Kiona Graham kiona.graham@mclaren.org
Contact:Principal Investigator: Abraham Salacata, MD

Sparrow Hospital
[Recruiting]
Lansing, Michigan, United States, 48912
Contact:Contact: Andrea Casler, RN, BSN 517-364-5734 andrea.casler@sparrow.org
Contact:Principal Investigator: John H Ip, MD

McLaren Macomb
[Recruiting]
Mount Clemens, Michigan, United States, 48043
Contact:Contact: Valentyna Onishchuk
Contact:Principal Investigator: Victor M Hunyadi, DO

Trinity Health Ann Arbor Hospital - Michigan Heart
[Recruiting]
Ypsilanti, Michigan, United States, 48197
Contact:Contact: Autumn Howe, RN, BSN 734-712-8387 ahowe@michiganheart.com
Contact:Principal Investigator: Edwin T Zishiri, MD

United States, Minnesota

Minneapolis VA Health Care System
[Recruiting]
Minneapolis, Minnesota, United States, 55417
Contact:Contact: Jill Morgan Jill.Morgan2@va.gov
Contact:Principal Investigator: Venkatakrishna Tholakanahalli, MD FHRS

United States, Missouri

University Hospital - University of Missouri
[Recruiting]
Columbia, Missouri, United States, 65211
Contact:Contact: Charles Donigian, RN 573-673-6162 donigianc@health.missouri.edu
Contact:Principal Investigator: Sandeep Gautam, MD MPH FHRS

SSM Health Saint Louis University Hospital
[Recruiting]
Saint Louis, Missouri, United States, 63110
Contact:Contact: Mary Lesko, RN, BSN mary.lesko@health.slu.edu;
Contact:Principal Investigator: Philip L Mar, MD, PharmD

United States, Nebraska

CHI Health Creighton University Medical Center - Bergan Mercy
[Recruiting]
Omaha, Nebraska, United States, 68124
Contact:Contact: Lois A Rasmussen, BSN, RN, CCRC 402-343-8539 lois.rasmussen@CHIhealth.com
Contact:Principal Investigator: Attila Roka, MD, PhD

United States, New Jersey

Cooper University Hospital
[Recruiting]
Camden, New Jersey, United States, 08103
Contact:Contact: Stephanie Vasey, BSN, RN +1 (856) 342-2000 Ext. 1095558 vasey-stephanie@CooperHealth.edu
Contact:Principal Investigator: Andrea M. Russo, MD, FACC, FHRS, FAHA

The Valley Hospital
[Recruiting]
Ridgewood, New Jersey, United States, 07450
Contact:Contact: Naomi Hatulan, BSN nhatula@valleyhealth.com
Contact:Principal Investigator: Dan Musat, MD

United States, New York

Albany Medical Center
[Recruiting]
Albany, New York, United States, 12208
Contact:Contact: Michael Gillogly, RN gillogm@amc.edu
Contact:Principal Investigator: Radmila Lyubarova, MD FACC FASE

NYC Health and Hospitals - Lincoln
[Recruiting]
Bronx, New York, United States, 10451
Contact:Contact: Beena DaCosta, RN, CCRC, MSN DSouzaB2@nychhc.org
Contact:Principal Investigator: Kenneth Ong, MD

NYC Health and Hospitals - Jacobi
[Recruiting]
Bronx, New York, United States, 10461
Contact:Contact: Cidney Schultz, RN cidney.schultz@nychhc.org
Contact:Principal Investigator: Michael J. Grushko, MD

NYC Health and Hospitals - North Central Bronx
[Recruiting]
Bronx, New York, United States, 10467
Contact:Contact: Raven Dwyer dwyerr1@nychhc.org
Contact:Principal Investigator: Michael Grushko, MD

NewYork-Presbyterian/Columbia University Irving Medical Center
[Recruiting]
New York, New York, United States, 10032
Contact:Contact: Esteban Ceballos ec3539@cumc.columbia.edu
Contact:Principal Investigator: Elaine Y. Wan, MD FACC FAHA FHRS

Memorial Sloan Kettering
[Recruiting]
New York, New York, United States, 10065
Contact:Contact: Justine Jorgenson jorgensj@mskcc.org
Contact:Principal Investigator: Ioanna Kosmidou, MD PHD

DiGiovanna Institute for Medical Education & Research
[Recruiting]
North Massapequa, New York, United States, 11758
Contact:Contact: Sheeba Abraham dfccresearch@gmail.com
Contact:Principal Investigator: Michael DiGiovanna, DO CPI

United States, North Carolina

Duke University Hospital
[Recruiting]
Durham, North Carolina, United States, 27705
Contact:Contact: Meghan E Pergola 919-418-0720 meghan.pergola@duke.edu
Contact:Principal Investigator: Sean D Pokorney, MD, MBA

Durham VA Health Care System
[Recruiting]
Durham, North Carolina, United States, 27705
Contact:Contact: Julienne W Reynolds, BS, BA julienne.reynolds@va.gov
Contact:Contact: Kathy Aristy, BSN kathy.aristy@va.gov
Contact:Principal Investigator: Albert Sun, MD

WakeMed Raleigh Campus
[Recruiting]
Raleigh, North Carolina, United States, 27610
Contact:Contact: LaMonica Daniel 919-350-7438 LADANIEL@wakemed.org
Contact:Principal Investigator: Kevin Manocha, MD

New Hanover Regional Medical Center
[Recruiting]
Wilmington, North Carolina, United States, 28411
Contact:Contact: Kenji Groesbeck Ken.Groesbeck@novanthealth.org
Contact:Principal Investigator: Meena Rao, MD MPH FACC

United States, North Dakota

Trinity Hospital
[Recruiting]
Minot, North Dakota, United States, 58702
Contact:Contact: Natalie Quam natalie.quam@trinityhealth.org
Contact:Principal Investigator: Samir Turk, MD

United States, Ohio

The MetroHealth System
[Recruiting]
Cleveland, Ohio, United States, 44109
Contact:Contact: Pete Leo, RN 216-778-2714 pleo@metrohealth.org
Contact:Principal Investigator: Ohad Ziv, MD

Kettering Health Dayton
[Recruiting]
Dayton, Ohio, United States, 45405
Contact:Contact: Clayton Gerberick clayton.gerberick@ketteringhealth.org
Contact:Principal Investigator: Sameh N. Khouzam, MD

Miami Valley Hospital
[Recruiting]
Dayton, Ohio, United States, 45409
Contact:Contact: Heather Bell, RN hrbell@premierhealth.com
Contact:Principal Investigator: Anurag Singh, MD

Kettering Medical Center
[Recruiting]
Kettering, Ohio, United States, 45429
Contact:Contact: Clayton Gerberick clayton.gerberick@ketteringhealth.org
Contact:Principal Investigator: Franklin Handel, MD, FACC

McLaren - St Lukes Hospital
[Recruiting]
Maumee, Ohio, United States, 43537
Contact:Contact: Regina Miyauchi Regina.Miyauchi@McLaren.org
Contact:Principal Investigator: Chuck Gbur, MD

Wooster Community Hospital Health System
[Recruiting]
Wooster, Ohio, United States, 44691
Contact:Contact: Erica Stahl, MSN, RN, APRN 330-263-8359 estahl@wchosp.org
Contact:Principal Investigator: Cyril Ofori, MD, FACC

United States, Oklahoma

Oklahoma City VA Health Care System
[Recruiting]
Oklahoma City, Oklahoma, United States, 73104
Contact:Contact: Stephen Farriester stephen.farriester@va.gov
Contact:Principal Investigator: Udho Thadani, MD (MBBS) MRCP FACC FAHA FCCS

University of Oklahoma Health Sciences Center
[Recruiting]
Oklahoma City, Oklahoma, United States, 73104
Contact:Contact: Michael H Stout, RN Michael-H-Stout@ouhsc.edu
Contact:Principal Investigator: Zain Asad, MD, MS, FACC

United States, Pennsylvania

Penn State Health Holy Spirit Medical Center
[Recruiting]
Camp Hill, Pennsylvania, United States, 17011
Contact:Contact: Nicole F Grassmyer, RN ngrassmyer@pennstatehealth.psu.edu
Contact:Principal Investigator: Safwat A Gassis, MD, FACC, MMM, CPEFHRS,

Penn State Health Milton S Hershey Medical Center
[Recruiting]
Hershey, Pennsylvania, United States, 17033
Contact:Contact: Katie Loffredo, RN kloffredo@pennstatehealth.psu.edu
Contact:Principal Investigator: Gerald Naccarelli, MD

Penn State Health St Joseph Medical Center - Main Campus
[Recruiting]
Reading, Pennsylvania, United States, 19605
Contact:Contact: Emese Futchko, RN,MSN efutchko@pennstatehealth.psu.edu
Contact:Principal Investigator: Christopher B Rogers, DO FACC FACOI

United States, Tennessee

Ascension Saint Thomas Midtown
[Recruiting]
Nashville, Tennessee, United States, 37236
Contact:Contact: Leslie Mosley, RN leslie.mosley1@ascension.org
Contact:Principal Investigator: Robert A Pickett, MD

United States, Texas

Ascension Seton Medical Center Austin
[Recruiting]
Austin, Texas, United States, 78723
Contact:Contact: Jessica Graykowski, RN Jessica.Graykowski@ascension.org
Contact:Contact: Sarah Benedict Sarah.Benedict@ascension.org
Contact:Principal Investigator: Thomas K Kurian, MD

Texas Health Fort Worth (FKA Texas Health Harris Methodist Hospital Fort Worth)
[Recruiting]
Fort Worth, Texas, United States, 76104
Contact:Contact: Rebecca Wade rebeccawade@texashealth.org
Contact:Principal Investigator: Nitin K Kulkarni, MD

Memorial Hermann - Texas Medical Center
[Recruiting]
Houston, Texas, United States, 77030
Contact:Contact: Zahra Sorouraddinabadi Zahra.Sorouraddin@uth.tmc.edu
Contact:Principal Investigator: Olasimbo Chiadika, MD MPH

Texas Institute of Cardiology
[Recruiting]
McKinney, Texas, United States, 75071
Contact:Contact: Hina Shafiq hshafiqresearch@ticardiology.com
Contact:Principal Investigator: Faisal Wahid, MD FACC FSCAI

Synapse Clinical Research
[Recruiting]
Missouri City, Texas, United States, 77549
Contact:Contact: Saba Irfan saba.irfan@synapseclinicalresearch.com
Contact:Principal Investigator: Naseer N. Khan, MD

University Hospital at University of Texas San Antonio
[Recruiting]
San Antonio, Texas, United States, 78229
Contact:Contact: Italia Herrera herrerai1@uthscsa.edu
Contact:Principal Investigator: Hemal M Nayak, MD FACC FHRS

United States, Utah

University of Utah Hospital
[Recruiting]
Salt Lake City, Utah, United States, 84132
Contact:Contact: Mija Wall 801-585-2904 mija.wall@hsc.utah.edu
Contact:Principal Investigator: Benjamin A Steinberg, MD, MHS, FACC, FHRS

United States, Virginia

Chippenham and Johnston Willis Medical Center
[Recruiting]
Richmond, Virginia, United States, 23225
Contact:Contact: Ariana Dickens ariana.dickens@hcahealthcare.com
Contact:Principal Investigator: Saumil R Shah, MD

Hunter Holmes McGuire VA Medical Center (AKA Richmond VA Medical Center)
[Recruiting]
Richmond, Virginia, United States, 23249
Contact:Contact: Kristina Baumgart Kristina.Baumgart@va.gov
Contact:Principal Investigator: Karoly Kaszala, MD PHD

United States, West Virginia

JW Ruby Memorial Hospital
[Recruiting]
Morgantown, West Virginia, United States, 26506
Contact:Contact: Marvin Hudson marvin.hudson1@wvumedicine.org
Contact:Principal Investigator: David Schwartzman, MD FHRS

United States, Wisconsin

Mayo Clinic Hospital - Franciscan Healthcare La Crosse
[Recruiting]
La Crosse, Wisconsin, United States, 54601
Contact:Contact: Janel Tunison, BS, CCRP,CSM 608-392-6880 tunison.janel@mayo.edu
Contact:Principal Investigator: Xiaoke Ken Liu, MD PhD

UW Health at the American Center (AKA UW Health East Madison Hospital)
[Recruiting]
Madison, Wisconsin, United States, 53718
Contact:Contact: Emily Wittrock ewittrock@medicine.wisc.edu
Contact:Principal Investigator: Matthew M Kalscheur, MD

University Hospital - University of Wisconsin-Madison
[Recruiting]
Madison, Wisconsin, United States, 53792
Contact:Contact: Emily J Wittrock, BS, CMA 608-264-1087 ewittrock@medicine.wisc.edu
Contact:Contact: Besa Jonuzi bjonuzi@wisc.edu
Contact:Principal Investigator: Matthew M Kalscheur, MD

Marshfield Medical Center
[Recruiting]
Marshfield, Wisconsin, United States, 54449
Contact:Contact: Megan Johnson, CCRP 715-389-5473 Ext. 95473 johnson.megan.a@marshfieldresearch.org
Contact:Principal Investigator: Shereif Rezkalla, MD

Marshfield Medical Center
[Recruiting]
Weston, Wisconsin, United States, 54476
Contact:Contact: Rebecca Ottosen ottosen.rebecca@marshfieldresearch.org
Contact:Principal Investigator: Sanjay Kumar, MD

References


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