RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Nova Scotia Health Authority • ClinicalTrials.gov ID: NCT07272902

Registry updated: 2026-10-20

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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

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

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

Conditions

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

Locations

QEII HSC — Halifax, Nova Scotia, Canada
Hamilton Health Sciences — Hamilton, Ontario, Canada
London Health Sciences Centre — London, Ontario, Canada
Montreal Heart Institute — Montreal, Quebec, Canada

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment