A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and Preserved Ejection Fraction (CABANA-RAFT HF): A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Nova Scotia Health Authority
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Feasibility of Trial Conduct
Study Overview
Brief Summary
This study is testing two different ways of treating atrial fibrillation (AF) in people who also have heart failure with mildly reduced or preserved heart function. Patients will randomly be assigned to either rhythm control using catheter ablation or rate control using medicines. The pilot phase will determine if a larger study can be successfully carried out to see which approach better improves survival, reduces hospitalizations, and enhances quality of life.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years
- •Diagnosis of atrial fibrillation (documented on Holter, rhythm strip, or ECG)
- •New York Heart Association (NYHA) class II-III heart failure
- •Left ventricular ejection fraction (LVEF) >40%
- •Meet specific NT-proBNP criteria:
- •If HF hospitalization within 6 months prior to screening: NT-proBNP >200 pg/ml (if not in AF at screening) or >600 pg/ml (if in AF at screening)
- •Otherwise: NT-proBNP >300 pg/ml (if not in AF at screening) or >900 pg/ml (if in AF at screening)
- •On stable guideline-directed medical therapy for ≥1 month
- •On stable diuretic dose for ≥2 weeks
- •Suitable for either ablation-based rhythm control or rate control strategy
Exclusion Criteria
- •Permanent atrial fibrillation diagnosis
- •Prior catheter ablation for atrial fibrillation
- •NYHA class IV heart failure
- •Rheumatic heart disease
- •Moderate or severe mitral stenosis
- •Mechanical mitral valve
- •Severe aortic stenosis or severe aortic/mitral regurgitation
- •Renal failure requiring dialysis
- •Contraindication to oral anticoagulation
- •Infiltrative cardiomyopathies
- •Complex congenital heart disease
- •Untreated thyroid disease
- •Acute coronary syndrome or coronary artery bypass surgery within 12 weeks
- •Participation in another clinical trial
- •Inability to provide informed consent
- •Other serious non-cardiovascular condition with life expectancy ≤1 year
- •Age <18 years
Arms & Interventions
Catheter Ablation (Rhythm Control Group)
Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study.
Intervention: Catheter Ablation for Atrial Fibrillation (Procedure)
Medical Therapy (Rate Control Group)
Participants in this group will take medications, with the dosages adjusted over the first few weeks to find the correct dosage.
Intervention: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin) (Drug)
Outcomes
Primary Outcomes
Feasibility of Trial Conduct
Time Frame: 12 months after randomization
Recruitment rate (patients recruited per center per month) and crossover rate (percentage of participants switching study arms). Feasibility will be defined as ≥0.7 patients enrolled per center per month and ≤10% crossover.
Secondary Outcomes
- Exercise Capacity (6-Minute Walk Distance)(Baseline, 12 months)
- Recruitment Metrics(Throughout 12-month recruitment)
- Quality of Life: EQ-5D (Euroquol 5D Questionnaire)(Baseline, 12 months)
- Composite of Cardiovascular Mortality and Heart Failure Hospitalization(Up to 12 months post-randomization)
- All-Cause Mortality(Up to 12 months)
- Cardiovascular Hospitalizations and ED Visits (Non-HF)(Up to 12 months)
- Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire(Baseline, 12 months)
- Atrial Fibrillation Burden(Baseline, 3, 6, and 12 months)
- Change in Left Ventricular Ejection Fraction (LVEF)(Baseline, 12 months)
- Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12)(Baseline, 12 months)
- Change in NT-proBNP levels(Baseline, 12 months)
Investigators
Ratika Parkash
Principal Investigator
Nova Scotia Health Authority