Ablation strategy for persistent atrial fibrillation using scar mapping

Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (Coast-AF) Randomized Clinical Trial

This study is testing a new personalized treatment for people with persistent atrial fibrillation to see if adding scar mapping to the usual procedure helps them feel better compared to just the standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 502 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Heart Institute Research Corporation (Academic / other)
• Locations: 15 sites (Calgary, Alberta and 14 other locations)
• Trial ID: NCT03347227 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a personalized catheter ablation strategy that incorporates atrial scar mapping alongside traditional pulmonary vein isolation in patients with persistent atrial fibrillation. It is a multicenter, randomized, single-blinded study involving 502 participants, divided into two groups to compare the outcomes of the tailored approach against pulmonary vein isolation alone. The study aims to gather comprehensive patient data prior to the procedure to better understand the arrhythmia's underlying mechanisms and improve treatment success rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic persistent atrial fibrillation who are indicated for catheter ablation.

Not a fit: Patients with a history of previous catheter ablation for atrial fibrillation or those with certain comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to higher success rates in treating persistent atrial fibrillation, improving patient outcomes.

How similar studies have performed: While there is limited data from multicenter randomized studies on this specific approach, the concept of scar-based ablation has shown promise in preliminary studies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years ;
2. Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF
3. 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;
4. Modified DR-FLASH score \>=4

4. Subjects must be able to provide informed consent.

Exclusion Criteria:

1. History of previous catheter ablation for AF or left atrial flutter;
2. History of previous surgical ablation for AF;
3. Known intracardiac thrombus;
4. Contraindication to systemic oral anticoagulation therapy;
5. Reversible causes of AF;
6. Hypertrophic cardiomyopathy;
7. Severe valvular disease (mitral/aortic stenosis or regurgitation);
8. Subjects that are pregnant or breastfeeding;
9. Comorbid condition with life expectancy \< 1 year

Where this trial is running

Calgary, Alberta and 14 other locations

• Libin Cardiovascular Institute — Calgary, Alberta, Canada (Recruiting)
• Vancouver General Hospital — Vancouver, British Columbia, Canada (Recruiting)
• QEII Health Sciences Centre, Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (Recruiting)
• Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
• London Health Sciences Centre — London, Ontario, Canada (Not_yet_recruiting)
• Southlake Regional Health Centre — Newmarket, Ontario, Canada (Recruiting)
• University of Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
• St. Michael's Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
• Rouge Valley Regional Heart Centre — Toronto, Ontario, Canada (Recruiting)
• Centre Hospitalier de l'Universite de Montreal (CHUM) — Montreal, Quebec, Canada (Recruiting)
• Sacre-Coeur Hospital — Montreal, Quebec, Canada (Recruiting)
• McGill University Health Centre — Montreal, Quebec, Canada (Recruiting)
• Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
• Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ) — Quebec City, Quebec, Canada (Recruiting)
• CIUSSS de L'Estrie-CHUS-Hopital Fleurimont — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Principal investigator: Pablo Nery, MD — Ottawa Heart Institute Research Corporation
• Study coordinator: Pablo Nery, MD

Conditions Atrial Fibrillation; AF ablation; Pulmonary vein isolation; Atrial scar ablation