Catheter ablation: Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
Study 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 low voltage area mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥18 years;
2. Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF;
3. Persistent AF defined as a sustained episode beyond 3 months in duration;
4. At least one episode of AF must have been documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study;
5. Modified DR-FLASH score \>=3
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
Primary outcome measure(s)
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
Trial sites (14)
Facility
City
Region
Status
Libin Cardiovascular Institute
Calgary
Alberta
Vancouver General Hospital
Vancouver
British Columbia
QEII Health Sciences Centre, Nova Scotia Health Authority
Halifax
Nova Scotia
Hamilton General Hospital
Hamilton
Ontario
London Health Sciences Centre
London
Ontario
Southlake Regional Health Centre
Newmarket
Ontario
University of Ottawa Heart Institute
Ottawa
Ontario
St. Michael's Hospital
Toronto
Ontario
Rouge Valley Regional Heart Centre
Toronto
Ontario
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal
Quebec
McGill University Health Centre
Montreal
Quebec
Montreal Heart Institute
Montreal
Quebec
Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ)
Québec
Quebec
CIUSSS de L'Estrie-CHUS-Hopital Fleurimont
Sherbrooke
Quebec
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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