Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication

Official title

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

Overview

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.

Interventions

• Procedure Catheter Ablation for Atrial Fibrillation
  Participants randomized to this arm will undergo catheter ablation within 4 weeks of randomization. Pulmonary vein isolation is required; additional ablation strategies may be applied at investigator discretion. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
• Drug Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)
  Participants randomized to this arm will receive pharmacologic therapy to achieve guideline-recommended heart rate control (resting HR \<80 bpm, \<110 bpm with exercise). Therapy may include beta-blockers, non-dihydropyridine calcium channel blockers, or digoxin. If adequate control is not achieved with medication, AV nodal ablation and pacing may be used. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.

Primary outcome measures

• Feasibility of Trial Conduct [Time frame: 12 months after randomization]

Secondary outcome measures (11)

• Composite of Cardiovascular Mortality and Heart Failure Hospitalization [Time frame: Up to 12 months post-randomization]
• All-Cause Mortality [Time frame: Up to 12 months]
• Cardiovascular Hospitalizations and ED Visits (Non-HF) [Time frame: Up to 12 months]
• Quality of Life: EQ-5D (Euroquol 5D Questionnaire) [Time frame: Baseline, 12 months]
• Quality of Life: AFEQT (Atrial Fibrillation Effect on Quality of Life) Questionnaire [Time frame: Baseline, 12 months]
• Quality of life- KCCQ-12 (Kansas City Cardiomyopathy Questionnaire-12) [Time frame: Baseline, 12 months]
• Atrial Fibrillation Burden [Time frame: Baseline, 3, 6, and 12 months]
• Change in NT-proBNP levels [Time frame: Baseline, 12 months]
• Change in Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline, 12 months]
• Exercise Capacity (6-Minute Walk Distance) [Time frame: Baseline, 12 months]
• Recruitment Metrics [Time frame: Throughout 12-month recruitment]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• QEII HSC — Halifax

Identifiers

NCT: NCT07272902 · CABANA-RAFT HF · 1032000

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗