Treating Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: Ablation or Medication
Recruiting · NCT07272902 · Interventional (participants receive a specific treatment) · Lead sponsor: Nova Scotia Health Authority
View the official record on ClinicalTrials.gov →Interventions studied
Catheter Ablation for Atrial FibrillationRate Control Medications (beta-blockers, calcium channel blockers, digoxin)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- QEII HSC - Halifax, Nova Scotia, Canada