Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation (COAST-AF RCT)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Catheter ablation

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:

i. 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 Type: Interventional
• Enrollment (Anticipated): 502
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pablo Nery, MD; Phone Number: 613-696-7272; Email: pnery@ottawaheart.ca
• Study Contact Backup: Name: Tammy Knight; Phone Number: 19080 613-696-7000; Email: tknight@ottawaheart.ca

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Recruiting
      • Libin Cardiovascular Institute
      • Principal Investigator: George Veenhuyzen, MD
  • British Columbia
    • Vancouver, British Columbia, Canada
      • Recruiting
      • Vancouver General Hospital
      • Principal Investigator: Jason Andrade, MD
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Recruiting
      • QEII Health Sciences Centre, Nova Scotia Health Authority
      • Contact: John Sapp, MD
  • Ontario
    • Hamilton, Ontario, Canada
      • Recruiting
      • Hamilton General Hospital
      • Contact: Jorge Wong, MD
      • Principal Investigator: Jorge Wong, MD
    • London, Ontario, Canada
      • Not yet recruiting
      • London Health Sciences Centre
      • Contact: Allan Skanes, MD
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Recruiting
      • Southlake Regional Health Centre
      • Contact: Atul Verma, MD
    • Ottawa, Ontario, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Contact: Pablo Nery, MD; Phone Number: 613-696-7272; Email: pnery@ottawaheart.ca
      • Principal Investigator: Pablo Nery, MD
    • Toronto, Ontario, Canada, M5B 1W8
      • Not yet recruiting
      • St. Michael's Hospital
      • Contact: Paul Angaran, MD
    • Toronto, Ontario, Canada
      • Recruiting
      • Rouge Valley Regional Heart Centre
      • Contact: Derek Yung, MD
      • Principal Investigator: Derek Yung, MD
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
      • Recruiting
      • Centre hospitalier de l'Université de Montréal (CHUM)
      • Contact: Jean-Marc Raymond, MD
      • Principal Investigator: Jean-Marc Raymond, MD
    • Montreal, Quebec, Canada, H4J 1C5
      • Recruiting
      • Sacré-Cœur Hospital
      • Contact: Mario Sturmer, MD
      • Principal Investigator: Mario Sturmer, MD
    • Montreal, Quebec, Canada
      • Recruiting
      • McGill University Health Centre
      • Principal Investigator: Jacqueline Joza, MD
    • Montreal, Quebec, Canada
      • Recruiting
      • Montreal Heart Institute
      • Contact: Laurent Macle, MD
      • Principal Investigator: Laurent Macle, MD
    • Quebec City, Quebec, Canada, G1V 4G5
      • Recruiting
      • Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ)
      • Contact: Isabelle Nault, MD
      • Principal Investigator: Isabelle Nault, MD
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Recruiting
      • CIUSSS de L'Estrie-CHUS-Hopital Fleurimont
      • Contact: Charles Dussault, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Atrial Fibrillation Ablation
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: Atrial Fibrillation Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation	Documented AF, Aflutter or AT by ECG, holter or external loop monitoring and has a duration of at least 30 seconds	day 91 post ablation to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AF burden	Documented amount of AF	At 12 months and 18 months
Need for repeat ablation procedure for AF, AFl or AT	Documented by ECG, holter or ECG loop recorder	Up to 18 months
Need for emergency room visits or hospitalization	Hospital admission for > 24 hours and emergency room admission	Up to 18 months
Incidence of any ECG documented AF with 90 days of ablation	Symptomatic or asymptomatic AF	up to 90 days
Time to first recurrence at 18 months according to sex and atrial scar extent	Recurrence of AF, AFl or AT	18 months
Composite safety outcome	Procedure related complications at any time (stroke, PV stenosis, pericarditis, cardiac perforation, major bleeding) and/or death	Up to 18 months
Total ablation delivery time	RF ablation time	Day of ablation procedure
Total procedure duration	Start of ablation to end of ablation	Day of ablation procedure
Quality of life analyses	Using EQ-5D general quality of life score, and AF severity scale (symptoms and functionality)	18 months

Collaborators and Investigators

• Sponsor: Ottawa Heart Institute Research Corporation
• Collaborators: Heart and Stroke Foundation of Canada
• Investigators: Principal Investigator: Pablo Nery, MD, Ottawa Heart Institute Research Corporation

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2018
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 16, 2017
• First Posted (Actual): November 20, 2017

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 3, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary vein isolation; AF ablation; Atrial scar ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 20170

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No