STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

NCT04428944 | Active Not Recruiting DMC

• 1 other identifier: MP-33-2021-2805
• Study Type: interventional
• Target: 617
• Locations: 8 countries
• Sites: 30

Brief Summary

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

1. 1.PV antral isolation alone (PVAI)
2. 2.PV antral isolation plus ablation of drivers (PVAI+drivers)
3. 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.

Conditions

Atrial Fibrillation

Keywords

ablation

Outcome Measures

Primary Outcomes (1)

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

  18 months

Secondary Outcomes (20)

• 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 at 18 months after one or more procedures on or off AAM

  18 months

• Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM

  18 months

• Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM

  18 months

Study Arms (3)

PV antral isolation alone (PVAI)

ACTIVE COMPARATOR

PV antral isolation alone (PVAI)

Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)

PV antral isolation plus ablation of drivers

ACTIVE COMPARATOR

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

Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)

PV antral isolation plus isolation of posterior wall

ACTIVE COMPARATOR

PV antral isolation plus isolation of LA posterior wall (PVAI+Box)

Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)

Interventions

Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI) PROCEDURE

Standard PVI

PV antral isolation alone (PVAI)

Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers) PROCEDURE

Standard PVI + Ablation of drivers in LA and RA

PV antral isolation plus ablation of drivers

Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box) PROCEDURE

Standard PVI + Electrical isolation of the posterior wall of the left atrium

PV antral isolation plus isolation of posterior wall

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years of age or older
• Patients undergoing first-time ablation procedure for AF
• Patients with persistent AF defined as a sustained episode more than 3 months but less than three years
• 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
• Patients whose AF has been refractory to at least one antiarrhythmic drug
• 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
• Patients must be able and willing to provide written informed consent to participate in the study

You may not qualify if:

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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Montreal Heart Institute: collaborator

Study Sites (32)

Brigham & Women'S Hosptial Inc.

Boston, Massachusetts, 02115, United States

Location

Canberra Heart Rhythm Foundation

Garran, Australian Capital Territory, Australia

Location

Royal Adelaide Hospital and Cardiovascular Centre

Adelaide, Australia

Location

Alfred Health

Melbourne, Australia

Location

Royal Melbourne Hospital

Parkville, Australia

Location

Medical University of Graz

Graz, Austria

Location

Ordensklinikum Linz GmbH

Linz, Austria

Location

OLV Hospital Aalst

Aalst, Belgium

Location

Antwerp University Hospital (UZA)

Edegem, Belgium

Location

AZ Sint-Jan

Ruddershove, Belgium

Location

University of Calgary Foothills

Calgary, Alberta, T2N 4N1, Canada

Location

Vancouver General Hospital

Vancouver, British Colombia, V5Z 1M9, Canada

Location

St. Paul's Hospital, Vancouver, BC

Vancouver, British Colombia, V6Z 1Y6, Canada

Location

Royal Jubilee Hospital

Victoria, British Colombia, V8R 1J8, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Southlake Regional Health Center

Newmarket, Ontario, L3Y 2P9, Canada

Location

Laurent Macle

Montreal, QC - Québec, H1T 1c8, Canada

Location

MUHC, McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

University of Ottawa Heart Institute

Ottawa, Quebec, K1Y 4W7, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

Hôpital Fleurimont, CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Hospital St-Joseph

Marseille, France

Location

Institut Mutualiste Montsouris

Paris, 75014, France

Location

Clinique du Tonkin

Villeurbanne, France

Location

Ospedale Generale Regionale F. Miulli

Acquaviva delle Fonti, Italy

Location

Dokkyo Medical University Koshigaya Hospital

Koshigaya, Saitama, Japan

Location

Juntendo University Hospital

Bunkyo City, Tokyo, Japan

Location

National University Corporation Kobe University

Chūōku, Japan

Location

Jikei University School of Med

Tokyo, Japan

Location

Minamino Cardiovascular Hospital

Tokyo, Japan

Location

Nihon University School of Medicine

Tokyo, Japan

Location

Hospital Clinic Barcelona

Barcelona, Spain

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Atul Verma, Dr.

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

• Laurent Macle, Dr.

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiologist electrophysiologist

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 11, 2020
• Study Start: June 1, 2021
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); US (1); AU (4); FR (3); BE (3); CA (11); IT (1); JP (6)