RAFT-AF Extend: Randomized Ablation-based AF Rhythm-control Versus Rate-control in Patients With HF and High-burden AF Extend
Study Details
Study Description
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 | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Ablation-based rhythm-control Ablation-based rhythm-control consisted of pulmonary vein isolation in paroxysmal atrial fibrillation, and additional ablation for persistent atrial fibrillation |
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| Rate-control Rate-control included AV-nodal blocking agents and AV node ablation with permanent pacing |
Outcome Measures
Primary Outcome Measures
- 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
- 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)
- Quality of Life MLHFQ [24 months]
Minnesota Living with Heart Failure Questionnaire
- Quality of Life AFEQT [24 months]
AF Effect on Quality-of-life,
- Quality of Life EQ5D [24 months]
EuroQol- 5 Dimension
- 6 Minute hall walk [24 months]
six minute hall walk
- NT-proBNP [24 months]
NT-proBNP blood meaure
- LV function [24 months]
Echo measure Left ventricular ejection fraction
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fundação Universitária de Cardiologia/Instituto de Cardiologia | Porto Alegre | Brazil | 90620-001 | |
| 2 | Libin Cardiovascular Institute | Calgary | Alberta | Canada | |
| 3 | Vancouver General Hospital | Vancouver | British Columbia | Canada | K4A 3B2 |
| 4 | Victoria Cardiac Arrhythmia Trials | Victoria | British Columbia | Canada | |
| 5 | Queen Elizabeth II Health Science | Halifax | Nova Scotia | Canada | |
| 6 | Hamilton Health Sciences Centre | Hamilton | Ontario | Canada | |
| 7 | Kingston General Hospital | Kingston | Ontario | Canada | |
| 8 | St. Mary's General Hospital | Kitchener | Ontario | Canada | |
| 9 | London Health Science Centre | London | Ontario | Canada | |
| 10 | University of Ottawa Heart Institute | Ottawa | Ontario | Canada | |
| 11 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | |
| 12 | Toronto General | Toronto | Ontario | Canada | |
| 13 | McGill University Health Centre | Montréal | Quebec | Canada | |
| 14 | Montreal Heart Institute | Montréal | Quebec | Canada | |
| 15 | Institut Univ.cardiologie/pneumologie de Québec | Quebec City | Quebec | Canada | |
| 16 | CHUS Le Centre hospitalier universitaire de Sherbrooke | Sherbrooke | Quebec | Canada | |
| 17 | Karolinska University Hospital | Stockholm | Sweden | ||
| 18 | National Taiwan University Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- Anthony Tang
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- V15Sep21