STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation (STARAF3)

May 5, 2026 updated by: Atul Verma, McGill University Health Centre/Research Institute of the McGill University Health Centre

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
617

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital and Cardiovascular Centre
      • Melbourne, Australia
        • Alfred Health
      • Parkville, Australia
        • Royal Melbourne Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia
        • Canberra Heart Rhythm Foundation
  • Austria
      • Graz, Austria
        • Medical University of Graz
      • Linz, Austria
        • Ordensklinikum Linz GMBH
  • Belgium
      • Aalst, Belgium
        • OLV Hospital Aalst
      • Edegem, Belgium
        • Antwerp University Hospital (UZA)
      • Ruddershove, Belgium
        • AZ Sint-Jan
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary Foothills
    • British Colombia
      • Vancouver, British Colombia, Canada, V6Z 1Y6
        • St. Paul's Hospital, Vancouver, BC
      • Vancouver, British Colombia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Victoria, British Colombia, Canada, V8R 1J8
        • Royal Jubilee Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton General Hospital
      • Newmarket, Ontario, Canada, L3Y 2P9
        • Southlake Regional Health Center
    • QC - Québec
      • Montreal, QC - Québec, Canada, H1T 1c8
        • Laurent Macle
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • MUHC, McGill University Health Centre
      • Ottawa, Quebec, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • Hôpital Fleurimont, CHUS
  • France
      • Marseille, France
        • Hospital St-Joseph
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • Villeurbanne, France
        • Clinique du Tonkin
  • Italy
      • Acquaviva delle Fonti, Italy
        • Ospedale Generale Regionale F. Miulli
  • Japan
      • Chūōku, Japan
        • National University Corporation Kobe University
      • Tokyo, Japan
        • Nihon University School of Medicine
      • Tokyo, Japan
        • Minamino Cardiovascular Hospital
      • Tokyo, Japan
        • Jikei University School of Med
    • Saitama
      • Koshigaya, Saitama, Japan
        • Dokkyo Medical University Koshigaya Hospital
    • Tokyo
      • Bunkyo City, Tokyo, Japan
        • Juntendo University Hospital
  • Spain
      • Barcelona, Spain
        • Hospital Clinic Barcelona
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women'S Hosptial Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM).
Time Frame: 18 months
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM
Time Frame: 18 months
18 months
Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM
Time Frame: 18 months
18 months
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM
Time Frame: 18 months
18 months
Freedom from documented AF > 30 seconds at 18 months after one procedure off AAM
Time Frame: 18 months
18 months
Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one procedure off AAM
Time Frame: 18 months
18 months
Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM
Time Frame: 18 months
18 months
Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM
Time Frame: 18 months
18 months
Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM
Time Frame: 18 months
18 months
Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM
Time Frame: 18 months
18 months
Each of the above success measures stratified by CHA2DS2-VASc score
Time Frame: 18 months
18 months
Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death
Time Frame: 18 months
18 months
Procedure duration
Time Frame: 18 months
18 months
Fluoroscopy time (dose)
Time Frame: 18 months
18 months
Radiofrequency time
Time Frame: 18 months
18 months
Number of repeat procedures
Time Frame: 18 months
18 months
Effect of each strategy on AF cycle length changes and AF termination
Time Frame: 18 months
18 months
Correlation of acute AF termination on long-term procedural outcome
Time Frame: 18 months
18 months
Quality of life measurements during follow-up using AFEQT questionnaire
Time Frame: 6-12-18 months
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)
Time Frame: 18 months
18 months
Quality of life measurements during follow-up using SF12 questionnaires
Time Frame: 6-12-18 months
SF36 questionnaires will be used at baseline, 6, 12 and 18 months
6-12-18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Montreal Heart Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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