Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion (RESTART)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT05477147 |
Recruitment Status :
Recruiting
First Posted : July 28, 2022
Last Update Posted : October 16, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atrial Fibrillation | Device: Catheter Ablation | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 92 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Re-Ablation Using a Tailored Approach Targeting EGM-Dispersion |
Actual Study Start Date : | March 17, 2023 |
Estimated Primary Completion Date : | February 2025 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment Group
Patients undergoing catheter ablation that qualify after initial screening.
|
Device: Catheter Ablation
Cardiac catheter ablation for recurrent AF after previous ablation (catheter or surgical). |
- Freedom from AF [ Time Frame: 1 year ]Percent of patient free from recurrent AF episodes of >30 seconds at 1 year after 1 study redo procedure

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients 21 years of age or older indicated for redo AF ablation
- Previous catheter or surgical ablation for paroxysmal AF, persistent AF, or long-standing persistent AF
- Documented symptomatic AF recurrences that occurred within the last 12 months and persisted beyond 3 months after the last AF ablation procedure
- Continuous anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- Patients must be able and willing to provide written informed consent to participate in the clinical trial
Exclusion Criteria:
- Previous ablation procedure-related complication (e.g. fistula, perforation, etc.)
- First AF ablation procedure indication was persistent AF lasting longer than 24 months
- Long-standing persistent AF recurrence prior to study redo procedure
- Previous AF ablation using VX1 software
- Severe obesity (BMI > 50)
- Very dilated Left Atrium (LA) (e.g. LA diameter > 55 mm and/or LA surface > 40 cm2 determined by 2D echocardiography)
- Patients with AF secondary to an obvious reversible cause
- Inadequate anticoagulation as defined in the inclusion criteria
- LA thrombus on Transesophageal Echocardiography (TEE)* or CT Scan prior to procedure
- Contraindications to anticoagulation (heparin, warfarin or NOAC)
- Patients who are or may potentially be pregnant
- Any cardiac surgery except catheter ablation within the past 2 months (60 days) (includes PCI)
- Myocardial infarction within the past 2 months (60 days)
- Previous AV valve surgery
- Patient diagnosed with hypertrophic cardiomyopathy
- History of blood clotting or bleeding abnormalities
- Documented arterial thromboembolic event (including TIA) within the past 12 months (365 days)
- Rheumatic Heart Disease
- Cardiac Sarcoidosis
- Chronic severe Heart Failure (NYHA functional class IV and/or LVEF < 25%)
- Awaiting cardiac transplantation or other cardiac surgery within the next 12 months (365 days)
- Unstable angina within the past month
- Acute illness or active systemic infection or sepsis
- AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- Diagnosed atrial myxoma
- Significant severe pulmonary disease (e.g. patients with restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease in GOLD stage IV) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms (e.g. unstable or untreated sleep apnea)
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment
- Enrollment in an investigational study evaluating another device, biologic, or drug
- Presence of intramural thrombus, tumor or other abnormality or condition that precludes vascular access, or manipulation of the catheter
- Life expectancy or other disease processes likely to limit survival to less than 12 months
- Acute Covid-19 infection (fever and/or biological inflammatory syndrome, and positive test documented)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05477147
Contact: Dan Guerrero | +1 (612) 227-1483 | daniel.guerrero@volta-medical.com |
United States, Florida | |
Ascension St. Vincent's Hospital | Recruiting |
Jacksonville, Florida, United States, 32204 | |
Contact: Jasmine Riley jasmine.vestal@ascension.org | |
Principal Investigator: Anthony Magnano, MD | |
United States, Kansas | |
Kansas City Cardiac Arrhythmia Research LLC | Recruiting |
Overland Park, Kansas, United States, 66211 | |
Contact: Donita Atkins donita.atkins@hcahealthcare.com | |
Principal Investigator: Dhanunjaya Lakkireddy, MD | |
United States, Missouri | |
Washington University | Recruiting |
Saint Louis, Missouri, United States, 63130 | |
Contact: Janice Amsler jmamsler@wustl.edu | |
Principal Investigator: Daniel Cooper, MD | |
United States, New York | |
Northwell Health System | Recruiting |
New York, New York, United States, 11030 | |
Contact: Kristie Coleman kcoleman1@northwell.edu | |
Principal Investigator: Stavros Mountantonakis, MD | |
United States, Ohio | |
The Ohio State University | Recruiting |
Columbus, Ohio, United States, 43210 | |
Contact: Meredith Reahm Meredith.Reahm@osumc.edu | |
Principal Investigator: John Hummel, MD | |
United States, Pennsylvania | |
Penn Presbyterian Medical Center | Recruiting |
Philadelphia, Pennsylvania, United States, 19104 | |
Contact: Katie Shoemaker katie.shoemaker@pennmedicine.upenn.edu | |
Principal Investigator: Benjamin D'Souza, MD | |
United States, Virginia | |
Inova Fairfax Hospital | Recruiting |
Fairfax, Virginia, United States, 22042 | |
Contact: Tracy Plummer tracy.plummer@inova.org | |
Principal Investigator: Haroon Rashid, MD | |
Belgium | |
OLV Aalst | Recruiting |
Aalst, Belgium | |
France | |
Hôpital Privé Jacques Cartier | Recruiting |
Massy, France | |
Clinique Pasteur | Recruiting |
Toulouse, France |
Responsible Party: | Volta Medical |
ClinicalTrials.gov Identifier: | NCT05477147 |
Other Study ID Numbers: |
CLIPL-01-003 |
First Posted: | July 28, 2022 Key Record Dates |
Last Update Posted: | October 16, 2023 |
Last Verified: | October 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Atrial fibrillation AF Artificial intelligence Catheter Ablation Ablation |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |