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Active, not recruiting Not applicable

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

NCT04428944 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2021-06-01
Last updated
2026-05-08

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)

Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI): Standard PVI

Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers): Standard PVI + Ablation of drivers in LA and RA

Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box): Standard PVI + Electrical isolation of the posterior wall of the left atrium

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (32)

FacilityCityRegionStatus
Brigham & Women'S Hosptial Inc. Boston Massachusetts
Canberra Heart Rhythm Foundation Garran Australian Capital Territory
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
Vancouver General Hospital Vancouver British Colombia
St. Paul's Hospital, Vancouver, BC Vancouver British Colombia
Royal Jubilee Hospital Victoria British Colombia
Hamilton General Hospital Hamilton Ontario
Southlake Regional Health Center Newmarket Ontario
Laurent Macle Montreal QC - Québec
MUHC, McGill University Health Centre Montreal Quebec
University of Ottawa Heart Institute Ottawa Quebec
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ) Québec Quebec
Hôpital Fleurimont, CHUS Sherbrooke Quebec
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
Juntendo University Hospital Bunkyo City Tokyo
National University Corporation Kobe University Chūōku 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

More McGill University Health Centre/Research Institute of the McGill University Health Centre trials in France

Official registry record

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.

View NCT04428944 on ClinicalTrials.gov ↗ ← All trials in France