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

Heart Failure Clinical Trial

— RAFT-AF Extend  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05118893
• Other study ID #: V15Sep21
• Status: Recruiting
• Start date: May 8, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 311
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Locations

Country	Name	City	State
Canada	Libin Cardiovascular Institute	Calgary	Alberta
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	McGill University Health Centre	Montréal	Quebec
Canada	Montreal Heart Institute	Montréal	Quebec
Canada	University of Ottawa Heart Institute	Ottawa	Ontario
Canada	CHUS Le Centre hospitalier universitaire de Sherbrooke	Sherbrooke	Quebec
Canada	Victoria Cardiac Arrhythmia Trials	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Anthony Tang

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	all-cause mortality	Death	24 months
Secondary	Heart Failure Events	HF Event ( admit > 24 hrs or urgent out patient or ER visit for IV diuretics)	24 months