STrategies for Catheter Ablation of PeRsistent Atrial Fibrlllation

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI); Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box); Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)

• Registration Number: NCT04428944
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

The objective of this study is to compare the efficacy of three different ablation strategies in patients with persistent AF:

1. PV antral isolation alone (PVAI)

2. PV antral isolation plus ablation of drivers (PVAI+drivers)

3. PV antral isolation plus isolation of posterior wall (PVAI+box) All three strategies will employ contemporary catheter ablation technology using more efficient open irrigated tip cooling and contact force sensing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-05
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2021-06-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-09
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 617

Inclusion Criteria

1. Patients 18 years of age or older
2. Patients undergoing first-time ablation procedure for AF
3. Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
4. Patients with symptomatic AF - symptomatic patients are those who have been aware of their AF at any time within the last 5 years prior to enrolment. Symptoms may include, but are not restricted to, palpitations, shortness of breath, chest pain, fatigue, left ventricular dysfunction, or other symptoms or any combination of the above
5. Patients whose AF has been refractory to at least one antiarrhythmic drug
6. At least one episode of AF must have been documented by ECG, holter, loop recorder, telemetry, trans-telephonic monitor or implanted device within the last 2 years from enrolment
7. Patients must be able and willing to provide written informed consent to participate in the study

Exclusion Criteria

1. Patients with paroxysmal AF (no episodes lasting > 7 days)
2. Patients with early persistent AF, sustained episode ≤ 3 months
3. Patients with very long lasting persistent AF (episodes lasting > 3 years)
4. Patients with CHA2DS2-VASc score of 0.
5. Patients for whom cardioversion or sinus rhythm will never be attempted/pursued
6. Patients with AF felt to be secondary to an obvious reversible cause
7. Patients with contraindication to oral anticoagulation or systemic anticoagulation with heparin
8. Patients with left atrial diameter > 60 mm in the parasternal long axis view
9. Patients who are pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PV antral isolation alone (PVAI)	Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)	PV antral isolation alone (PVAI)
PV antral isolation plus isolation of posterior wall	Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)	PV antral isolation plus isolation of LA posterior wall (PVAI+Box)
PV antral isolation plus ablation of drivers	Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)	PV antral isolation plus ablation of drivers (PVAI+drivers)

Primary Outcome Measures

Name	Time	Method
Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).	18 months

Secondary Outcome Measures

Name	Time	Method
Change in AF burden post-ablation procedure (% of time in AF)	18 months
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM	18 months
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM	18 months
Each of the above success measures stratified by CHA2DS2-VASc score	18 months
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM	18 months
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM	18 months
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM	18 months
Radiofrequency time	18 months
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM	18 months
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM	18 months
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM	18 months
Quality of life measurements during follow-up using AFEQT questionnaire	6-12-18 months	AFEQT questionnaires will be used at baseline, 6, 12 and 18 months
Procedure duration	18 months
Fluoroscopy time (dose)	18 months
Effect of each strategy on AF cycle length changes and AF termination	18 months
Correlation of acute AF termination on long-term procedural outcome	18 months
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM	18 months
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death	18 months
Number of repeat procedures	18 months
Quality of life measurements during follow-up using SF12 questionnaires	6-12-18 months	SF36 questionnaires will be used at baseline, 6, 12 and 18 months

Trial Locations

Locations (32)

Brigham & Women'S Hosptial Inc.; 🇺🇸 Boston, Massachusetts, United States

Canberra Heart Rhythm Foundation; 🇦🇺 Garran, Australian Capital Territory, Australia

Royal Adelaide Hospital and Cardiovascular Centre; 🇦🇺 Adelaide, Australia

Alfred Health; 🇦🇺 Melbourne, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Australia

Medical University of Graz; 🇦🇹 Graz,, Austria

Ordensklinikum Linz GmbH; 🇦🇹 Linz, Austria

OLV Hospital Aalst; 🇧🇪 Aalst, Belgium

Antwerp University Hospital (UZA); 🇧🇪 Edegem, Belgium

AZ Sint-Jan; 🇧🇪 Ruddershove, Belgium

University of Calgary Foothills; 🇨🇦 Calgary, Alberta, Canada

Vancouver General Hospital; 🇨🇦 Vancouver,, British Colombia, Canada

St. Paul's Hospital, Vancouver, BC; 🇨🇦 Vancouver, British Colombia, Canada

Royal Jubilee Hospital; 🇨🇦 Victoria, British Colombia, Canada

Hamilton General Hospital; 🇨🇦 Hamilton, Ontario, Canada

Southlake Regional Health Center; 🇨🇦 Newmarket, Ontario, Canada

Laurent Macle; 🇨🇦 Montreal, QC - Québec, Canada

MUHC, McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada

University of Ottawa Heart Institute; 🇨🇦 Ottawa, Quebec, Canada

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ); 🇨🇦 Québec, Quebec, Canada

Hôpital Fleurimont, CHUS; 🇨🇦 Sherbrooke, Quebec, Canada

Hospital St-Joseph; 🇫🇷 Marseille, France

Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Clinique du Tonkin; 🇫🇷 Villeurbanne, France

Ospedale Generale Regionale F. Miulli; 🇮🇹 Acquaviva delle Fonti, Italy

Dokkyo Medical University Koshigaya Hospital; 🇯🇵 Koshigaya, Saitama, Japan

Juntendo University Hospital; 🇯🇵 Bunkyo City, Tokyo, Japan

National University Corporation Kobe University; 🇯🇵 Chuo Ku, Japan

Jikei University School of Med; 🇯🇵 Tokyo, Japan

Minamino Cardiovascular Hospital; 🇯🇵 Tokyo, Japan

Nihon University School of Medicine; 🇯🇵 Tokyo, Japan

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain