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

Randomized Ablation-based Atrial Fibrillation Rhythm-control Versus Rate-control Trial in Patients With Heart Failure and High-burden Atrial Fibrillation Extend

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

Study Overview

• Status: Completed
• Conditions: Heart Failure; Atrial Fibrillation

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 Type: Observational
• Enrollment (Actual): 324

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • Libin Cardiovascular Institute
  • British Columbia
    • Victoria, British Columbia, Canada
      • Victoria Cardiac Arrhythmia Trials
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • Queen Elizabeth II Health Science
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton Health Sciences Centre
    • Kingston, Ontario, Canada
      • Kingston General Hospital
    • Kitchener, Ontario, Canada
      • St. Mary's General Hospital
    • London, Ontario, Canada
      • London Health Science Centre
    • Ottawa, Ontario, Canada
      • University of Ottawa Heart Institute
  • Quebec
    • Montréal, Quebec, Canada
      • McGill University Health Centre
    • Montréal, Quebec, Canada
      • Montreal Heart Institute
    • Sherbrooke, Quebec, Canada
      • CHUS Le Centre hospitalier universitaire de Sherbrooke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All eligible patients enrolled in the original RAFT-AF Study

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ablation-based rhythm-control; Ablation-based rhythm-control consisted of pulmonary vein isolation in paroxysmal atrial fibrillation, and additional ablation for persistent atrial fibrillation
Rate-control; Rate-control included AV-nodal blocking agents and AV node ablation with permanent pacing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of mortality and Heart Failure Events	Death or HF Event ( admit > 24 hrs or urgent out patient or ER visit for IV diuretics)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	Death	24 months
Heart Failure Events	HF Event ( admit > 24 hrs or urgent out patient or ER visit for IV diuretics)	24 months

Collaborators and Investigators

• Sponsor: Anthony Tang
• Investigators: Principal Investigator: Anthony Tang, London Health Sciences Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2023
• Primary Completion (Actual): August 30, 2024
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: atrial fibrillation; heart failure; long-term follow up
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Heart Failure; Atrial Fibrillation
• Other Study ID Numbers: V15Sep21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No