The Impact of "First-Line" Rhythm Therapy on AF Progression (PROGRESSIVE-AF)
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ClinicalTrials.gov Identifier: NCT05514860 |
Recruitment Status :
Active, not recruiting
First Posted : August 25, 2022
Last Update Posted : October 10, 2022
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Condition or disease | Intervention/treatment | Phase |
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Atrial Fibrillation | Procedure: Cryoballoon-based PVI Drug: Anti-Arrhythmic Drug Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 303 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Impact of "First-Line" Rhythm Therapy on AF Progression |
Actual Study Start Date : | January 2017 |
Actual Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | November 2022 |
Arm | Intervention/treatment |
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Active Comparator: Cryoballoon-based PVI
Sinus rhythm control via a pulmonary vein isolation (PVI) ("first-line") procedure utilizing the the Arctic Front Cryoballoon Procedure.
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Procedure: Cryoballoon-based PVI
Patients randomized to first-line cryoballoon (CB) ablation will have the pulmonary vein isolation procedure performed according to standard clinical practice using the Arctic Front Cryoballoon ablation catheter. No anti-arrhythmic drugs will be prescribed in this arm. |
Active Comparator: Anti-Arrhythmic Drug Therapy
Sinus rhythm control via the use of anti-arrhythmic drug (AAD) therapy ("first-line") based on local clinical practice, and according to guideline-suggested drug management for symptomatic patients with paroxysmal AF.
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Drug: Anti-Arrhythmic Drug Therapy
Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according to guideline-suggested drug management for symptomatic patients with paroxysmal AF. |
- Time to First Occurrence of Persistent Atrial Tachyarrhythmia [ Time Frame: Between 91 days following treatment initiation to final follow-up (~36 months) ]time to first occurrence of symptomatic or asymptomatic persistent atrial tachyarrhythmia (atrial fibrillation [AF], atrial flutter [AFL], or atrial tachycardia [AT]), as defined as the first occurrence of a continuous atrial tachyarrhythmia episode lasting ≥ 7 days in duration, or lasting 48 hours to 7 days in duration but requiring cardioversion for termination, as documented by implantable loop recorder.
- Atrial Fibrillation Burden [ Time Frame: Treatment initiation to final follow-up (~36 months) ]Percentage time in atrial fibrillation
- Health Related Quality of Life [ Time Frame: Baseline, 12, 24, and 36 months following treatment initiation ]Change in disease-specific AFEQT score, and Generic EQ-5D score from baseline
- Symptom Status [ Time Frame: Baseline, 12, 24, and 36 months following treatment initiation ]Number of participants free from symptoms attributable to atrial fibrillation
- Healthcare utilisation [ Time Frame: Treatment initiation to final follow-up (~36 months) ]Number of participants experiencing an emergency department visit, cardioversion, and hospitalization >24 hours in a healthcare facility
- Non-Protocol Ablation Procedure [ Time Frame: Treatment initiation to final follow-up (~36 months) ]Number of patients experiencing a repeat ablation procedures in those randomized to first line catheter ablation, or any ablation procedure performed in patients randomized to AAD therapy
- Safety Outcomes related to Ablation or AAD therapy [ Time Frame: Treatment initiation to final follow-up (~36 months) ]Number of patients experiencing a major complication of ablation, or significant adverse drug events (death, ventricular pro-arrhythmia, syncope, hypotension, pacemaker insertion).
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Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Non-permanent AF documented on a 12 lead ECG, Trans Telephonic Monitoring (TTM) or Holter monitor within the last 24 months
- Age of 18 years or older on the date of consent
- Candidate for ablation based on AF that is symptomatic
- Informed Consent
Exclusion Criteria:
- Regular (daily) use of a class 1 or 3 antiarrhythmic drug (pill-in-the-pocket AAD use is permitted) at sufficient therapeutic doses according to guidelines (flecainide >50 mg BID, sotalol >80 mg BID, propafenone >150 mg BID Previous left atrial (LA) ablation or LA surgery
- AF due to reversible cause (e.g. hyperthyroidism, cardiothoracic surgery)
- Active Intracardiac Thrombus
- Pre-existing pulmonary vein stenosis or PV stent
- Pre-existing hemidiaphragmatic paralysis
- Contraindication to anticoagulation or radiocontrast materials
- Left atrial anteroposterior diameter greater than 5.5 cm by transthoracic echocardiography
- Cardiac valve prosthesis
- Clinically significant (moderately-severe, or severe) mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA, or coronary artery stenting during the 3-month period preceding the consent date
- Cardiac surgery during the three-month interval preceding the consent date
- Significant congenital heart defect (including atrial septal defects or PV abnormalities but not including PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) less than 35%
- Hypertrophic cardiomyopathy (septal or posterior wall thickness >1.5 cm)
- Significant Chronic Kidney Disease (CKD - eGFR <30 µMol/L)
- Uncontrolled hyperthyroidism
- Cerebral ischemic event (strokes or TIAs) during the six-month interval preceding the consent date
- Pregnancy
- Life expectancy less than one (1) year
- Currently participating or anticipated to participate in any other clinical trial of a drug, device or biologic that has the potential to interfere with the results of this study
- Unwilling or unable to comply fully with study procedures and follow-up
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): NCT05514860
Principal Investigator: | Jason Andrade | Vancouver General Hospital |
Responsible Party: | Jason Andrade, Principal Investigator, University of British Columbia |
ClinicalTrials.gov Identifier: | NCT05514860 |
Other Study ID Numbers: |
H16-00617_SRG-15-P15-001 |
First Posted: | August 25, 2022 Key Record Dates |
Last Update Posted: | October 10, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Pathologic Processes Anti-Arrhythmia Agents |