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Atrial FibrillationSTARAF3NCT04428944

STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

A study testing Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI), Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers) and Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box) in people with Atrial Fibrillation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 32 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI), Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers) and Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
617 participants
Where
32 sitesin 9 countries
Study dates
1 Jun 2021to Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

32 sites in 9 countries.

32 sites in 9 countries

Canada11 sites

  • University of Calgary Foothills

    Calgary, Alberta, T2N 4N1

  • Hamilton General Hospital

    Hamilton, Ontario, L8L 2X2

  • Laurent Macle

    Montreal, QC - Québec, H1T 1c8

  • MUHC, McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Southlake Regional Health Center

    Newmarket, Ontario, L3Y 2P9

  • University of Ottawa Heart Institute

    Ottawa, Quebec, K1Y 4W7

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

    Québec, Quebec, G1V 4G5

  • Hôpital Fleurimont, CHUS

    Sherbrooke, Quebec, J1H 5H3

  • Vancouver General Hospital

    Vancouver, British Colombia, V5Z 1M9

  • St. Paul's Hospital, Vancouver, BC

    Vancouver, British Colombia, V6Z 1Y6

  • Royal Jubilee Hospital

    Victoria, British Colombia, V8R 1J8

Other trials in Canada

Japan6 sites

  • Juntendo University Hospital

    Bunkyo City, Tokyo

  • National University Corporation Kobe University

    Chūōku

  • Dokkyo Medical University Koshigaya Hospital

    Koshigaya, Saitama

  • Jikei University School of Med

    Tokyo

  • Minamino Cardiovascular Hospital

    Tokyo

  • Nihon University School of Medicine

    Tokyo

Other trials in Japan

Australia4 sites

  • Royal Adelaide Hospital and Cardiovascular Centre

    Adelaide

  • Canberra Heart Rhythm Foundation

    Garran, Australian Capital Territory

  • Alfred Health

    Melbourne

  • Royal Melbourne Hospital

    Parkville

Other trials in Australia

Belgium3 sites

  • OLV Hospital Aalst

    Aalst

  • Antwerp University Hospital (UZA)

    Edegem

  • AZ Sint-Jan

    Ruddershove

Other trials in Belgium

France3 sites

  • Hospital St-Joseph

    Marseille

  • Institut Mutualiste Montsouris

    Paris, 75014

  • Clinique du Tonkin

    Villeurbanne

Other trials in France

Austria2 sites

  • Medical University of Graz

    Graz

  • Ordensklinikum Linz GmbH

    Linz

Other trials in Austria

United States1 site

  • Brigham & Women'S Hosptial Inc.

    Boston, Massachusetts, 02115

Other trials in United States

Italy1 site

  • Ospedale Generale Regionale F. Miulli

    Acquaviva delle Fonti

Other trials in Italy

Spain1 site

  • Hospital Clinic Barcelona

    Barcelona

Other trials in Spain

About this study

Official title: 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.
Being tested
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)
Keywords
ablation
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)Procedure or surgery

    Standard PVI

  • Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)Procedure or surgery

    Standard PVI + Ablation of drivers in LA and RA

  • Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)Procedure or surgery

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

Study groups in NCT04428944
Study groupRoleWhat they receive
PV antral isolation alone (PVAI)Active comparatorPV antral isolation alone (PVAI)
Receives: Procedure: Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)
PV antral isolation plus ablation of driversActive comparatorPV antral isolation plus ablation of drivers (PVAI+drivers)
Receives: Procedure: Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)
PV antral isolation plus isolation of posterior wallActive comparatorPV antral isolation plus isolation of LA posterior wall (PVAI+Box)
Receives: Procedure: Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 18 months

Secondary outcomes (20)

  1. Freedom from documented AF > 30 seconds at 18 months after one procedure on or off AAM

    Measured: 18 months

  2. Freedom from documented AF > 30 seconds at 18 months after one or more procedures on or off AAM

    Measured: 18 months

  3. Freedom from documented atrial arrhythmia > 30 seconds at 18 months after one or more procedures on or off AAM

    Measured: 18 months

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

    Measured: 18 months

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

    Measured: 18 months

  6. Freedom from documented AF > 30 seconds at 18 months after one or more procedures off AAM

    Measured: 18 months

  7. Freedom from documented atrial arrhythmia > 30 seconds after one or more procedures off AAM

    Measured: 18 months

  8. Freedom from documented symptomatic AF > 30 seconds at 18 months after one procedure on or off AAM

    Measured: 18 months

  9. Freedom from documented symptomatic atrial arrhythmia > 30 seconds after one procedure on or off AAM

    Measured: 18 months

  10. Each of the above success measures stratified by CHA2DS2-VASc score

    Measured: 18 months

  11. Incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, esophageal injury, phrenic nerve palsy, and death

    Measured: 18 months

  12. Procedure duration

    Measured: 18 months

  13. Fluoroscopy time (dose)

    Measured: 18 months

  14. Radiofrequency time

    Measured: 18 months

  15. Number of repeat procedures

    Measured: 18 months

  16. Effect of each strategy on AF cycle length changes and AF termination

    Measured: 18 months

  17. Correlation of acute AF termination on long-term procedural outcome

    Measured: 18 months

  18. Quality of life measurements during follow-up using AFEQT questionnaire

    AFEQT questionnaires will be used at baseline, 6, 12 and 18 months

    Measured: 6-12-18 months

  19. Quality of life measurements during follow-up using SF12 questionnaires

    SF36 questionnaires will be used at baseline, 6, 12 and 18 months

    Measured: 6-12-18 months

  20. Change in AF burden post-ablation procedure (% of time in AF)

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2020
  2. Study start1 Jun 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
617 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04428944
Sponsor's protocol ID
MP-33-2021-2805
Acronym
STARAF3
Status last verified
May 2026
First submitted
5 Jun 2020
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Macle L, Sebag F, Yamane T, Champagne J, Romero J, Scherr D, Roux JF, Deyell MW, Hayashi H, Amit G, Sadek M, Novak P, Kistler PM, Grimaldi M, Essebag V, Raymond-Paquin A, Roca-Luque I, Sanders P, Zei P, Nery P, Dyrda K, Joza J, Steinberg C, Ha A, Quadros K, Harada M, Andrade J, Verma A. Design and rationale of a multicenter randomized trial assessing strategies for catheter ablation of persistent atrial fibrillation- The STAR AF 3 trial. Am Heart J. 2026 Oct 22:107632. doi: 10.1016/j.ahj.2026.107632. Online ahead of print.

    PubMed 42913989

Questions about this trial

What is this clinical trial studying?

A study testing Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI), Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers) and Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box) in people with Atrial Fibrillation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 32 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Canada, Japan, Australia, Belgium, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom from documented atrial arrhythmia ≥ 30 seconds at 18 months after one ablation procedure on or off antiarrhythmic medications (AAM). (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04428944, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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