Randomized Ablation-based AF Rhythm-control Versus Rate-control in Patients With HF and High-burden AF Extend

NCT ID: NCT05118893

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-08
• Study Completion Date: 2024-08-30

Brief Summary

This is an extended follow up study of the original RAFT-AF Study. The RAFT-AF study was a multi-centre randomized controlled trial with a prospective randomized open blinded endpoint trial (PROBE) design. Patients were randomized to either catheter ablation-based rhythm control of AF as compared to rate control of AF

Detailed Description

The RAFT-AF Extend Trial is a continued follow up of patients enrolled in the original RAFT-AF Study (ClinicalTrials.gov, NCT01420393), which evaluated whether ablation-based rhythm-control compared to rate-control improves clinical outcomes in patients with heart failure and atrial fibrillation. It was a randomised, open-label clinical trial, with blinded endpoint adjudication, conducted in 21 institutions in four countries. Patients with atrial fibrillation, New York Heart Association class II-III heart failure, and elevated NT-proBNP were included. Patients were randomized (1:1) to ablation-based rhythm-control or rate-control, stratified by left ventricular ejection fraction (≤45% and >45%). Ablation-based rhythm-control consisted of pulmonary vein isolation in paroxysmal atrial fibrillation, and additional ablation for persistent atrial fibrillation. Rate-control included AV-nodal blocking agents and AV node ablation with permanent pacing. The primary outcome was a composite of mortality and heart failure events, with a minimum follow up of two years. Secondary outcomes included left ventricular ejection fraction, quality of life, six-minute walk test and NT-proBNP. The primary analysis was intention-to-treat. From December 1, 2011, to January 20, 2018, 411 patients were randomised to ablation-based rhythm-control (n=214) or rate-control (n=197). The primary outcome occurred in 50 (23·4%) patients in the ablation-based rhythm-control group and 64 (32·5%) patients in the rate-control group (hazard ratio 0·71 95% CI (0·49, 1·03), p=0·066). Quality of life, six-minute walk distance, left ventricular ejection fraction, and NT-proBNP demonstrated greater improvements in the ablation-based rhythm-control group.

In patients with high burden atrial fibrillation and heart failure, there was no statistically significant reduction of all-cause mortality or heart failure events with ablation-based rhythm-control versus rate-control. With the hazard ratio equivalent to the minimal clinically important difference and the result near statistical significance, there is a probable clinically important benefit of ablation-based rhythm-control over rate-control.

This RAFT-AF Extend study is to extend follow up in RAFT-AF patients for an additional 24 months in order to have sufficient power to definitely determine if ablation-based rhythm control of atrial fibrillation is superior to rate control for the reduction of the primary outcome of all-cause mortality or heart failure event in patient with atrial fibrillation and heart failure.

Conditions

Atrial Fibrillation; Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Ablation-based rhythm-control

Ablation-based rhythm-control consisted of pulmonary vein isolation in paroxysmal atrial fibrillation, and additional ablation for persistent atrial fibrillation

No interventions assigned to this group

Rate-control

Rate-control included AV-nodal blocking agents and AV node ablation with permanent pacing

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

All patients previously enrolled and randomized in the RAFT-AF Study that are eligible to enroll

Exclusion Criteria

• Did not participate in the original RAFT-AF Study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthony Tang

OTHER

Sponsor Role: lead

Responsible Party

Anthony Tang

Professor of Medicine, Western University

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anthony Tang

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Research Institute

Locations

Libin Cardiovascular Institute

Calgary, Alberta, Canada

Victoria Cardiac Arrhythmia Trials

Victoria, British Columbia, Canada

Queen Elizabeth II Health Science

Halifax, Nova Scotia, Canada

Hamilton Health Sciences Centre

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

St. Mary's General Hospital

Kitchener, Ontario, Canada

London Health Science Centre

London, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

CHUS Le Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

V15Sep21

Identifier Type: -

Identifier Source: org_study_id