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

Completed

• Conditions: Heart Failure; Atrial Fibrillation

• Registration Number: NCT05118893
• Lead Sponsor: Anthony Tang

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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-11-03
• Study First Posted: 2021-11-12
• Study Start: 2023-05-08
• Primary Completion: 2024-08-30
• Study Completion: 2024-08-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of mortality and Heart Failure Events	24 months	Death or HF Event ( admit \> 24 hrs or urgent out patient or ER visit for IV diuretics)

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	24 months	Death
Heart Failure Events	24 months	HF Event ( admit \> 24 hrs or urgent out patient or ER visit for IV diuretics)

Trial Locations

Locations (11)

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; 🇨🇦 Montréal, Quebec, Canada

Montreal Heart Institute; 🇨🇦 Montréal, Quebec, Canada

CHUS Le Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada