Characterization of Arrhythmia Substrate to Ablate Persistent Atrial Fibrillation

NCT03347227 | Active Not Recruiting DMC

• 1 other identifier: 20170
• Study Type: interventional
• Target: 502
• Locations: 1 country
• Sites: 14

Brief Summary

A multicentre, parallel group, two arm, single-blinded randomized clinical trial, assessing the efficacy of a patient-tailored catheter ablation (CA) strategy guided by atrial low voltage area mapping in addition to pulmonary vein isolation (PVI) when compared to PVI alone in patients with persistent atrial fibrillation (AF).

Conditions

Atrial Fibrillation

Keywords

AF ablation; Pulmonary vein isolation; Atrial scar ablation

Outcome Measures

Primary Outcomes (1)

• Rate of documented (>30s) AF, atrial flutter or atrial tachycardia occuring from day 91 to 18 months post ablation

  Documented AF, Aflutter or AT by ECG, holter or external loop monitoring and has a duration of at least 30 seconds

  day 91 post ablation to 18 months

Secondary Outcomes (10)

• Composite safety endpoints

  Up to 18 months

• AF burden

  At 12 months and 18 months

• Need for repeat ablation procedure for AF, AFl or AT

  Up to 18 months

• Need for emergency room visits or hospitalization

  Up to 18 months

• Quality of Life assessment with EQ5D

  Baseline to 18months

Study Arms (2)

Pulmonary Vein Isolation

ACTIVE COMPARATOR

Wide area circumferential catheter ablation for pulmonary vein isolation

Procedure: Catheter ablation

Pulmonary Vein Isolation and atrial low voltage area ablation

EXPERIMENTAL

Wide area circumferential catheter ablation for pulmonary vein isolation and atrial low voltage area ablation

Procedure: Catheter ablation

Interventions

Catheter ablation PROCEDURE

Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation

Also known as: Atrial Fibrillation Ablation

Pulmonary Vein Isolation; Pulmonary Vein Isolation and atrial low voltage area ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years;
• Subjects with symptomatic persistent AF AND clinically indicated catheter ablation for AF;
• Persistent AF defined as a sustained episode beyond 3 months in duration;
• At least one episode of AF must have been documented on 12-lead ECG, Holter monitor, loop monitor or trans-telephonic monitor (TTM) within 36 months of enrollment in the study;
• Modified DR-FLASH score \>=3
• \. Subjects must be able to provide informed consent.

You may not qualify if:

• History of previous catheter ablation for AF or left atrial flutter;
• History of previous surgical ablation for AF;
• Known intracardiac thrombus;
• Contraindication to systemic oral anticoagulation therapy;
• Reversible causes of AF;
• Hypertrophic cardiomyopathy;
• Severe valvular disease (mitral/aortic stenosis or regurgitation);
• Subjects that are pregnant or breastfeeding;
• Comorbid condition with life expectancy \< 1 year

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead
• Heart and Stroke Foundation of Canada: collaborator

Study Sites (14)

Libin Cardiovascular Institute

Calgary, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

QEII Health Sciences Centre, Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 1V7, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Southlake Regional Health Centre

Newmarket, Ontario, L3Y 2P9, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Rouge Valley Regional Heart Centre

Toronto, Ontario, Canada

Location

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, H2W 1T8, Canada

Location

McGill University Health Centre

Montreal, Quebec, Canada

Location

Montreal Heart Institute

Montreal, Quebec, Canada

Location

Institute Universitaire de Cardiologie et Pneumologie du Quebec (IUCPQ)

Québec, Quebec, G1V 4G5, Canada

Location

CIUSSS de L'Estrie-CHUS-Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Pablo Nery, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, parallel arm randomized clinical trial

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: August 24, 2018
• Primary Completion: April 23, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 11, 2026

Record last verified: 2026-04

Locations

CA (14)