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

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ClinicalTrials.gov Identifier: NCT05118893
Recruitment Status : Recruiting
First Posted : November 12, 2021
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Anthony Tang, Lawson Health Research Institute

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

Condition or disease
Atrial Fibrillation Heart Failure

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.

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Study Type : Observational
Estimated Enrollment : 311 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Randomized Ablation-based Atrial Fibrillation Rhythm-control Versus Rate-control Trial in Patients With Heart Failure and High-burden Atrial Fibrillation Extend
Actual Study Start Date : May 8, 2023
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : October 30, 2023

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Composite of mortality and Heart Failure Events [ Time Frame: 24 months ]
    Death or HF Event ( admit > 24 hrs or urgent out patient or ER visit for IV diuretics)


Secondary Outcome Measures :
  1. all-cause mortality [ Time Frame: 24 months ]
    Death

  2. Heart Failure Events [ Time Frame: 24 months ]
    HF Event ( admit > 24 hrs or urgent out patient or ER visit for IV diuretics)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All eligible patients enrolled in the original RAFT-AF Study
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05118893


Locations
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Canada, Alberta
Libin Cardiovascular Institute Not yet recruiting
Calgary, Alberta, Canada
Contact: Stephen Wilton, MD         
Canada, British Columbia
Vancouver General Hospital Not yet recruiting
Vancouver, British Columbia, Canada, K4A 3B2
Contact: Matthew Bennett, MD         
Victoria Cardiac Arrhythmia Trials Not yet recruiting
Victoria, British Columbia, Canada
Principal Investigator: Larry Sterns, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Science Not yet recruiting
Halifax, Nova Scotia, Canada
Contact: Ratika Parkash, MD         
Canada, Ontario
Hamilton Health Sciences Centre Not yet recruiting
Hamilton, Ontario, Canada
Principal Investigator: Jeff Healey, MD         
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada
Principal Investigator: Damian Redfearn, MD         
St. Mary's General Hospital Not yet recruiting
Kitchener, Ontario, Canada
Contact: Mary Radyk, RN    519-749-6578 ext 2503    mradyk@smgh.ca   
Principal Investigator: Umjeet Jolly, MD         
London Health Science Centre Not yet recruiting
London, Ontario, Canada
Contact: Peter Leong-Sit, MD         
University of Ottawa Heart Institute Not yet recruiting
Ottawa, Ontario, Canada
Contact: Pablo Nery, MD         
Canada, Quebec
McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada
Contact: Vidal Essebag, M.D.         
Montreal Heart Institute Not yet recruiting
Montréal, Quebec, Canada
Contact: Lena Rivard, M.D.         
CHUS Le Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada
Contact: Jean-Francois Roux, M.D.    819-346-1110    marie-claude.grenier.ciussse-chus@ssss.gouv.qc.ca   
Sponsors and Collaborators
Anthony Tang
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Responsible Party: Anthony Tang, Professor of Medicine, Western University, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT05118893    
Other Study ID Numbers: V15Sep21
First Posted: November 12, 2021    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anthony Tang, Lawson Health Research Institute:
atrial fibrillation
heart failure
long-term follow up
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes