STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation (STARAF3)

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 615
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caroline Girard; Phone Number: 4058 514-376-3330; Email: caroline.girard@icm-mhi.org

Study Locations

• Australia
  • Adelaide, Australia
    • Recruiting
    • Royal Adelaide Hospital and Cardiovascular Centre
    • Contact: Prashanthan Sanders, MD
  • Parkville, Australia
    • Recruiting
    • Royal Melbourne Hospital
    • Principal Investigator: Jonathan Kalman, MD
  • Australian Capital Territory
    • Garran, Australian Capital Territory, Australia
      • Recruiting
      • Canberra Heart Rhythm Foundation
      • Principal Investigator: Rajeev Pathak, MD
• Austria
  • Graz,, Austria
    • Recruiting
    • Medical University of Graz
    • Contact: Daniel Scherr, MD
  • Linz, Austria
    • Recruiting
    • Ordensklinikum Linz GmbH
    • Contact: Helmut Pürerfellner, MD
• Belgium
  • Aalst, Belgium
    • Recruiting
    • OLV Hospital Aalst
    • Contact: Tom De Potter, MD
  • Edegem, Belgium
    • Recruiting
    • Antwerp University Hospital (UZA)
    • Contact: Andrea Sarkozy, MD
  • Ruddershove, Belgium
    • Recruiting
    • AZ Sint-Jan
    • Principal Investigator: Sebastien Knecht, MD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • Recruiting
      • University of Calgary Foothills
      • Contact: Carlos Morillo, MD
  • British Colombia
    • Vancouver, British Colombia, Canada, V6Z 1Y6
      • Recruiting
      • St. Paul's Hospital, Vancouver, BC
      • Contact: Marc Deyell, MD
    • Vancouver,, British Colombia, Canada, V5Z 1M9
      • Recruiting
      • Vancouver General Hospital
      • Contact: Jason Andrade, MD
    • Victoria, British Colombia, Canada, V8R 1J8
      • Recruiting
      • Royal Jubilee Hospital
      • Contact: Paul Novak, MD
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton General Hospital
      • Contact: Guy Amit, MD
    • Newmarket, Ontario, Canada, L3Y 2P9
      • Recruiting
      • Southlake Regional Health Center
      • Contact: Mouhannad Sadek, MD
  • QC - Québec
    • Montreal, QC - Québec, Canada, H1T 1c8
      • Recruiting
      • Laurent Macle
      • Contact: Laurent Macle, MD; Phone Number: 5143763330
      • Contact: Caroline Girard; Phone Number: 4058 5143763330; Email: caroline.girard@icm-mhi.org
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • MUHC, McGill University Health Centre
      • Contact: Vidal Essebag, MD
    • Ottawa, Quebec, Canada, K1Y 4W7
      • Recruiting
      • University of Ottawa Heart Institute
      • Principal Investigator: Pablo Nery, MD
    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
      • Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
      • Contact: Jean Champagne, MD
    • Sherbrooke, Quebec, Canada, J1H 5H3
      • Recruiting
      • Hôpital Fleurimont, CHUS
      • Contact: Jean-François Roux, MD
• France
  • Marseille, France
    • Recruiting
    • Hospital St-Joseph
    • Contact: Clément Bars, MD
  • Montpellier, France
    • Recruiting
    • CHU Arnaud de Villeneuve
    • Contact: Jean-Luc Pasquié, MD
  • Paris, France, 75014
    • Recruiting
    • Institut Mutualiste Montsouris
    • Contact: Frederic Sebag, MD
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur
    • Contact: Jean-Paul Albenque, MD
  • Villeurbanne, France
    • Recruiting
    • Clinique du Tonkin
    • Contact: Cyril Durand, MD
• Italy
  • Acquaviva delle Fonti, Italy
    • Recruiting
    • Ospedale Generale Regionale F. Miulli
    • Principal Investigator: Massimo Grimaldi, MD
• Japan
  • Chuo Ku, Japan
    • Recruiting
    • National University Corporation Kobe University
    • Principal Investigator: Koji Fukuzawa, MD
  • Tokyo, Japan
    • Recruiting
    • Nihon University School of Medicine
    • Principal Investigator: Yasuo Okumura, MD
  • Tokyo, Japan
    • Recruiting
    • Jikei University School of Med
    • Principal Investigator: Teichii Yamane, MD
  • Tokyo, Japan
    • Recruiting
    • Minamino Cardiovascular Hospital
    • Principal Investigator: Koichiro Ejima, MD
  • Saitama
    • Koshigaya, Saitama, Japan
      • Recruiting
      • Dokkyo Medical University Koshigaya Hospital
      • Principal Investigator: Shiro Nakahara, MD
  • Tokyo
    • Bunkyo City, Tokyo, Japan
      • Recruiting
      • Juntendo University Hospital
      • Principal Investigator: Hidemori Hayashi, MD
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women'S Hosptial Inc.
      • Principal Investigator: Jorge E.Romero, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PV antral isolation alone (PVAI)	Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI); Standard PVI
Active Comparator: PV antral isolation plus ablation of drivers; PV antral isolation plus ablation of drivers (PVAI+drivers)	Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers); Standard PVI + Ablation of drivers in LA and RA
Active Comparator: PV antral isolation plus isolation of posterior wall; PV antral isolation plus isolation of LA posterior wall (PVAI+Box)	Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box); Standard PVI + Electrical isolation of the posterior wall of the left atrium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Collaborators: Montreal Heart Institute
• Investigators: Principal Investigator: Atul Verma, Dr., McGill University Health Centre/Research Institute of the McGill University Health Centre; Principal Investigator: Laurent Macle, Dr., Montreal Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: MP-33-2021-2805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No