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

Nova Scotia Health Authority (NSHA)

Status: Not yet enrolling

Conditions: Rhythm Control; Atrial Fibrillation (AF); Heart Failure With Preserved Ejection Fraction (HFPEF); Heart Failure With Mildly Reduced Ejection Fraction; Rate Control

Treatments: Procedure: Catheter Ablation for Atrial Fibrillation; Drug: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)

Study type: Interventional

Funder types: Other

Identifiers

NCT07272902

1032000 (Other Identifier)

CABANA-RAFT HF

Details and patient eligibility

About

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.

Enrollment: 84 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Catheter Ablation (Rhythm Control Group)

Active Comparator group

Description:

Participants in this group will undergo catheter ablation procedure, scheduled within 4 weeks of joining the study.

Treatment:

Procedure: Catheter Ablation for Atrial Fibrillation

Medical Therapy (Rate Control Group)

Active Comparator group

Description:

Participants in this group will take medications, with the dosages adjusted over the first few weeks to find the correct dosage.

Treatment:

Drug: Rate Control Medications (beta-blockers, calcium channel blockers, digoxin)