Strategies for Catheter Ablation of Persistent Atrial Fibrillation: a Randomized, Comparative Study

Status: Active_not_recruiting
Location: See all (32) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham & Women'S Hosptial Inc.
Boston
Other Locations
Australia
Royal Adelaide Hospital and Cardiovascular Centre
Adelaide
Canberra Heart Rhythm Foundation
Garran
Alfred Health
Melbourne
Royal Melbourne Hospital
Parkville
Austria
Medical University of Graz
Graz
Ordensklinikum Linz GmbH
Linz
Belgium
OLV Hospital Aalst
Aalst
Antwerp University Hospital (UZA)
Edegem
AZ Sint-Jan
Ruddershove
Canada
University of Calgary Foothills
Calgary
Hamilton General Hospital
Hamilton
Laurent Macle
Montreal
MUHC, McGill University Health Centre
Montreal
Southlake Regional Health Center
Newmarket
University of Ottawa Heart Institute
Ottawa
Institut universitaire de cardiologie et de pneumologie de Québec (IUCPQ)
Québec
Hôpital Fleurimont, CHUS
Sherbrooke
St. Paul's Hospital, Vancouver, BC
Vancouver
Vancouver General Hospital
Vancouver
Royal Jubilee Hospital
Victoria
France
Hospital St-Joseph
Marseille
Institut Mutualiste Montsouris
Paris
Clinique du Tonkin
Villeurbanne
Italy
Ospedale Generale Regionale F. Miulli
Acquaviva Delle Fonti
Japan
Juntendo University Hospital
Bunkyo City
National University Corporation Kobe University
Chūōku
Dokkyo Medical University Koshigaya Hospital
Koshigaya
Jikei University School of Med
Tokyo
Minamino Cardiovascular Hospital
Tokyo
Nihon University School of Medicine
Tokyo
Spain
Hospital Clinic Barcelona
Barcelona
Time Frame
Start Date: 2021-06-01
Completion Date: 2027-12
Participants
Target number of participants: 617
Treatments
Active_comparator: PV antral isolation alone (PVAI)
PV antral isolation alone (PVAI)
Active_comparator: PV antral isolation plus ablation of drivers
PV antral isolation plus ablation of drivers (PVAI+drivers)
Active_comparator: PV antral isolation plus isolation of posterior wall
PV antral isolation plus isolation of LA posterior wall (PVAI+Box)
Related Therapeutic Areas
Sponsors
Leads: McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators: Montreal Heart Institute

This content was sourced from clinicaltrials.gov