RecruitingNot ApplicableNCT07272902

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

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

Sponsor

Nova Scotia Health Authority

Enrollment

84 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Atrial Fibrillation (AF)Heart Failure With Preserved Ejection Fraction (HFpEF)Heart Failure With Mildly Reduced Ejection Fraction Rate Control Rhythm Control

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria17

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

Interventions

PROCEDURECatheter 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.

DRUGRate 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.