COAST-AF RCT: Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation
Study Details
Study Description
Brief Summary
A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial scar mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The optimal CA strategy for persistent AF remains unknown. Current data highlight the need for a better understanding of the substrate and mechanisms of arrhythmia maintenance in this population. Atrial scar-based catheter ablation has recently emerged as a promising strategy for ablation of AF. However, the available data has limitations that preclude definitive conclusions regarding the utility of this strategy (no data from multicenter, randomized studies available). Further research is needed to assess the role of scar-based ablation for persistent AF.
The Investigators hypothesize that catheter ablation of persistent AF (PeAF) tailored to abolish abnormal atrial substrate identified by intracardiac atrial scar mapping in addition to pulmonary vein isolation (PVI) will result in higher procedural success rates when compared to PVI alone.
The study will recruit 502 patients with PeAF (251 per treatment arm) who are candidates for CA ablation of AF according to the treating physician (and in agreement with current practice guidelines). Subjects will be recruited over a 42 month period. The total duration of the study is 60 months.
Prior to undergoing catheter ablation subjects will be seen by the investigator/ research assistant and the following data will be collected:
- Age and sex ii. Structural heart disease if present iii. CHADS2VASc score iv. DR-FLASH score v. NYHA class vi. Current medications vii. Duration of uninterrupted AF viii. Height and weight ix. Echocardiogram and other cardiac imaging results (within previous 12 months, including assessment of left ventricular ejection fraction, left atrial volume and valve function) x. ECG, Holter or loop monitor recording (within past 36 months) documenting AF.
Subjects will be randomly assigned in a 1:1 ratio to undergo wide area circumferential ablation for pulmonary vein isolation (PVI- control arm) or wide area circumferential ablation PVI and scar ablation (experimental arm). Randomization will be stratified by centre and by sex. Subjects will be randomized prior to the procedure.
Enrolled subjects will have a clinical follow-up visit at 3, 6, 12 and 18 months after the ablation procedure. A 14-day continuous ambulatory ECG monitor will be completed at each visit. The results of monitoring will be interpreted at a centralized core lab, and the results will be adjudicated by an arrhythmia specialist blinded to treatment group. A total of three questionnaires will be administered throughout the study, each at a specific time point. The Quality of Life (EQ-5D), CCS-Severity of AF scale, and Atrial Fibrillation Effect on Quality of life (AFEQT) will be completed at baseline, and at the 12-month and 18 month visit.
Concomitant medical therapy will be selected according to the treating physician. All subjects will be maintained on systemic oral anticoagulation for at least 2 months following catheter ablation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Pulmonary Vein Isolation Wide area circumferential catheter ablation for pulmonary vein isolation |
Procedure: Catheter ablation
Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
Other Names:
|
| Experimental: Pulmonary Vein Isolation and scar ablation Wide area circumferential catheter ablation for pulmonary vein isolation and scar ablation |
Procedure: Catheter ablation
Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation [day 91 post ablation to 18 months]
Documented AF, Aflutter or AT by ECG, holter or external loop monitoring and has a duration of at least 30 seconds
Secondary Outcome Measures
- AF burden [At 12 months and 18 months]
Documented amount of AF
- Need for repeat ablation procedure for AF, AFl or AT [Up to 18 months]
Documented by ECG, holter or ECG loop recorder
- Need for emergency room visits or hospitalization [Up to 18 months]
Hospital admission for > 24 hours and emergency room admission
- Incidence of any ECG documented AF with 90 days of ablation [up to 90 days]
Symptomatic or asymptomatic AF
- Time to first recurrence at 18 months according to sex and atrial scar extent [18 months]
Recurrence of AF, AFl or AT
- Composite safety outcome [Up to 18 months]
Procedure related complications at any time (stroke, PV stenosis, pericarditis, cardiac perforation, major bleeding) and/or death
- Total ablation delivery time [Day of ablation procedure]
RF ablation time
- Total procedure duration [Day of ablation procedure]
Start of ablation to end of ablation
- Quality of life analyses [18 months]
Using EQ-5D general quality of life score, and AF severity scale (symptoms and functionality)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age ≥18 years ;
-
Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF
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At least one episode of AF that is sustained beyond 3 months in duration ; documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study;
-
Modified DR-FLASH score >=4
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Subjects must be able to provide informed consent.
Exclusion Criteria:
-
History of previous catheter ablation for AF or left atrial flutter;
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History of previous surgical ablation for AF;
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Known intracardiac thrombus;
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Contraindication to systemic oral anticoagulation therapy;
-
Reversible causes of AF;
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Hypertrophic cardiomyopathy;
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Severe valvular disease (mitral/aortic stenosis or regurgitation);
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Subjects that are pregnant or breastfeeding;
-
Comorbid condition with life expectancy < 1 year
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Libin Cardiovascular Institute | Calgary | Alberta | Canada | |
| 2 | Vancouver General Hospital | Vancouver | British Columbia | Canada | |
| 3 | QEII Health Sciences Centre, Nova Scotia Health Authority | Halifax | Nova Scotia | Canada | B3H 1V7 |
| 4 | Hamilton General Hospital | Hamilton | Ontario | Canada | |
| 5 | London Health Sciences Centre | London | Ontario | Canada | |
| 6 | Southlake Regional Health Centre | Newmarket | Ontario | Canada | L3Y 2P9 |
| 7 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | K1Y 4W7 |
| 8 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
| 9 | Rouge Valley Regional Heart Centre | Toronto | Ontario | Canada | |
| 10 | Centre Hospitalier de l'Universite de Montreal (CHUM) | Montreal | Quebec | Canada | H2W 1T8 |
| 11 | Sacre-Coeur Hospital | Montreal | Quebec | Canada | H4J 1C5 |
| 12 | McGill University Health Centre | Montreal | Quebec | Canada | |
| 13 | Montreal Heart Institute | Montreal | Quebec | Canada | |
| 14 | Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ) | Quebec City | Quebec | Canada | G1V 4G5 |
| 15 | CIUSSS de L'Estrie-CHUS-Hopital Fleurimont | Sherbrooke | Quebec | Canada | J1H 5N4 |
Sponsors and Collaborators
- Ottawa Heart Institute Research Corporation
- Heart and Stroke Foundation of Canada
Investigators
- Principal Investigator: Pablo Nery, MD, Ottawa Heart Institute Research Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20170