Atrial Fibrillation (AF)Heart Failure With Mildly Reduced Ejection FractionHeart Failure With Preserved Ejection Fraction (HFPEF)Rate ControlRhythm Control
Investigational drug(s) / intervention(s)
Catheter Ablation for Atrial FibrillationRate Control Medications (beta-blockers, calcium channel blockers, digoxin)
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.
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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
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
Primary outcome measure(s)
Feasibility of Trial Conduct — 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.
Trial sites (1)
Facility
City
Region
Status
QEII HSC
Halifax
Nova Scotia
Recruiting
More Nova Scotia Health Authority trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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