STrategies for Catheter Ablation of peRsistent Atrial Fib... | NCT04428944

Studies
STrategies for Catheter Ablation of peRsistent Atrial Fibrlllation

NCT04428944

Sponsor

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

Status

Active, not recruiting

Last Update Posted

May 8, 2026Actual

Enrollment

617Actual

Phase

Not Applicable

Conditions

Atrial Fibrillation

Interventions

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)

Countries

United States
Australia
Austria
Belgium
Canada
France
Italy
Japan
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2021Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Jun 5, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2026

Last Update Posted Date

May 8, 2026Actual

Name	Class
Montreal Heart Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

617Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)	Procedure	Standard PVI	PV antral isolation alone (PVAI)

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Brigham & Women'S Hosptial Inc.		Boston	Massachusetts	02115	United States
Canberra Heart Rhythm Foundation

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms