Clinical trial NCT05118893: Randomized Ablation-based AF Rhythm-control Versus Rate-control in Patients With HF and High-burden 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Heart Failure
Keywords: atrial fibrillation
heart failure
long-term follow up
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients enrolled in the original RAFT-AF Study

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.

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

Primary outcomes:
measure: Composite of mortality and Heart Failure Events
timeFrame: 24 months
Secondary outcomes:
measure: all-cause mortality
timeFrame: 24 months
measure: Heart Failure Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Libin Cardiovascular Institute
state: Alberta
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Science
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Centre
state: Ontario
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
city: Kitchener
country: Canada
facility: St. Mary's General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS Le Centre hospitalier universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: London Health Sciences Research Institute
name: Anthony Tang
role: PRINCIPAL_INVESTIGATOR
References: