Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— COAST-AF RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03347227
• Other study ID #: 20170
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2018
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Ottawa Heart Institute Research Corporation
• Contact: Pablo Nery, MD
• Phone: 613-696-7272
• Email: pnery[@]ottawaheart.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 502
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Catheter ablation
Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Heart Institute Research Corporation	Heart and Stroke Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

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