Atrial Fibrillation (AF) Heart failure with mildly reduced ejection fraction Heart failure with preserved ejection fraction (HFPEF)
Conditions
Interventions
Group 1: Procedure/Surgery: Catheter Ablation for Atrial Fibrillation
Participants randomized to this arm will undergo catheter ablation within 4 weeks of randomization. Pulmonary vein isolation is re
additional ablation strategies may be applied at investigator discretion. Guideline-directed medical therapy for atrial fibrillation and heart failure will also be provided.
Group 2: Drug: Rate Contro
Sponsors
QEII Health Sciences Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Feasibility of Trial Conduct Assessment method: 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. Timepoint: 12 months after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome [1]Composite of Cardiovascular Mortality and Heart Failure Hospitalization Assessment method [1]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). Timepoint [1]Up to 12 months post-randomization Secondary outcome [2]Cardiovascular Hospitalizations and ED Visits (Non-HF) Assessment method [2]Number of hospitalizations or emergency department visits for other cardiovascular causes, including atrial fibrillation. Timepoint [2]Up to 12 months Secondary outcome [3]Quality of Life: EQ-5D, AFEQT, Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) Assessment method [3]Change in patient-reported quality of life scores using validated instruments. Timepoint [3]Baseline, 12 months Secondary outcome [4]Atrial Fibrillation Burden Assessment method [4]Proportion of time in atrial fibrillation as measured by Holter monitoring and symptom-triggered ECG recordings Timepoint [4]Baseline, 3, 6, and 12 months Secondary outcome [5]Change in NT-proBNP levels Assessment method [5]Change in plasma NT-proBNP levels from baseline to follow-up Timepoint [5]Baseline, 12 months Secondary outcome [6]Change in Left Ventricular Ejection Fraction (LVEF) Assessment method [6]Change in LVEF as measured by echocardiography Timepoint [6]Baseline, 12 months Secondary outcome [7]Exercise Capacity (6-Minute Walk Distance) Assessment method [7]Change in distance walked in 6 minutes from baseline to follow-up Timepoint [7]Baseline, 12 months Secondary outcome [8]Recruitment Metrics Assessment method [8]Recruitment ration of male vs. female participants, refusal rates and reasons. Timepoint [8]Throughout 12-month recruitment Secondary outcome [9]Procedural Complications Assessment method [9]Symptomatic pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusi | — |
Countries
Canada
Contacts
Public ContactRatika Parkash
QEII Health Sciences Centre
Outcome results
None listed