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.
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%
Permanent atrial fibrillation diagnosis
Prior catheter ablation for atrial fibrillation
NYHA class IV heart failure
Rheumatic heart disease
Parallel
Catheter Ablation for Atrial Fibrillation
Procedure/SurgeryParticipants 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)
DrugParticipants 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.
Feasibility of Trial Conduct
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.
Composite of Cardiovascular Mortality and Heart Failure Hospitalization
Time to first event of cardiovascular death (due to MI, sudden cardiac death, HF, stroke, CV procedures, CV bleeding, or other CV cause) or hospitalization for heart failure (admission \>24h, ED visit, or unscheduled IV diuretic administration).
All-Cause Mortality
Death from any cause
Cardiovascular Hospitalizations and ED Visits (Non-HF)
Number of hospitalizations or emergency department visits for other cardiovascular causes, including atrial fibrillation.
Quality of Life: EQ-5D (Euroquol 5D Questionnaire)
EQ5D Will include responses from the Euroquol 5D questionnaire
Procedural Complications
Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring transfusion.
Antiarrhythmic Drug Adverse Events
Incidence of drug-related toxicities (e.g., thyroid, hepatic, pulmonary, proarrhythmia)
All-Cause Death
Number of deaths from any cause
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Nova Scotia Health Authority
Lead sponsor
Heart and Stroke Foundation of Canada
Collaborator
