Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale - 06/12/22

Doi : 10.1016/j.ahj.2022.08.010

Pablo B. Nery, MD ^a,^⁎ , George A. Wells, PhD ^a,^b, Atul Verma, MD ^c, Jacqueline Joza, MD ^c, Girish M. Nair, MBBS, MSc ^a, George Veenhuyzen, MD ^d, Jason Andrade, MD ^e, Isabelle Nault, MD ^f, Jorge A. Wong, MD ^g, Markus Sikkel, MD ^h, Vidal Essebag, MD, PhD ^c,^o, Laurent Macle, MD ⁱ, John Sapp, MD ^j, Jean-Francois Roux, MD ^k, Allan Skanes, MD ^l, Paul Angaran, MD ^m, Paul Novak, MD ^h, Damian Redfearn, MD ⁿ, Mehrdad Golian, MD ^a, Calum J. Redpath, MD ^a, Marcio Sturmer, MD ^o, David Birnie, MD ^a
^a Division of Cardiology, Department of Medicine, University of Ottawa Heart Institute, Ottawa, Canada.
^b Cardiovascular Research Methods Center, University of Ottawa Heart Institute, Ottawa, Canada.
^c McGill University Health Center, Montreal, Quebec, Canada
^d Libin Cardiovascular Institute, University of Calgary, Calgary, Canada
^e Vancouver General Hospital, University of British Columbia,Vancouver, Canada
^f Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ), Quebec City, Quebec, Canada
^g Hamilton Health Sciences, McMaster University, Hamilton, Ontario, Canada
^h Victoria Cardiac Arrhythmia Trials, Victoria, British Columbia, Canada
ⁱ Montreal Heart Institute, Montreal, Québec, Canada
^j Queen Elizabeth II Health Sciences, Halifax, Nova Scotia, Canada
^k CHUS-Sherbrooke, Sherbrooke, Quebec, Canada
^l Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
^m St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada
ⁿ Kingston General Hospital, Kingston, Ontario, Canada.
^o Hôpital Sacré-Cœur, Université de Montréal, Montréal, Québec, Canada

^⁎Reprint requests: Pablo B. Nery MD, Associate Professor of Medicine, University of Ottawa Heart Institute, 40 Ruskin Street, Room H1285, Ottawa, Canada.Associate Professor of MedicineUniversity of Ottawa Heart Institute40 Ruskin Street, Room H1285OttawaCanada

Résumé

Background

Atrial low voltage area (LVA) catheter ablation has emerged as a promising strategy for ablation of persistent atrial fibrillation (AF). It is unclear if catheter ablation of atrial LVA increases treatment success rates in patients with persistent AF.

Objective

The primary aim of this trial is to assess the potential benefit of adjunctive catheter ablation of atrial LVA in addition to pulmonary vein isolation (PVI) in patients with persistent AF, when compared to PVI alone. The secondary aims are to evaluate safety outcomes, the quality of life and the healthcare resource utilization.

Methods/design

A multicenter, prospective, parallel-group, 2-arm, single-blinded randomized controlled trial is under way (NCT03347227). Patients who are candidates for catheter ablation for persistent AF will be randomly assigned (1:1) to either PVI alone or PVI + atrial LVA ablation. The primary outcome is 18-month documented event rate of atrial arrhythmia (AF, atrial tachycardia or atrial flutter) post catheter ablation. Secondary outcomes include procedure-related complications, freedom from atrial arrhythmia at 12 months, AF burden, need for emergency department visits/hospitalization, need for repeat ablation for atrial arrhythmia, quality of life at 12 and 18 months, ablation time, and procedure duration.

Discussion

Characterization of Arrhythmia Mechanism to Ablate Atrial Fibrillation (COAST-AF) is a multicenter randomized trial evaluating ablation strategies for catheter ablation. We hypothesize that catheter ablation of atrial LVA in addition to PVI will result in higher procedural success rates when compared to PVI alone in patients with persistent AF.

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Plan

Follow-up and clinical management

Study outcomes

Sample size calculation

Planned statistical analyses

Study management and safety

Study setting and timeline

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Vol 254

P. 133-140 - décembre 2022 Retour au numéro

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Characterization of arrhythmia substrate to ablate persistent atrial fibrillation (COAST-AF): Randomized controlled trial design and rationale - 06/12/22

Résumé

Background

Objective

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