Ablation versus medication for atrial fibrillation in people with preserved or mildly reduced heart function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot trial enrolls adults with atrial fibrillation and heart failure with preserved or mildly reduced ejection fraction (LVEF >40%) and NYHA class II–III symptoms, assigning them to rhythm control with catheter ablation or rate control with medications such as beta-blockers, calcium channel blockers, or digoxin. The pilot phase will test feasibility and gather preliminary outcome data on survival, heart failure hospitalizations, and patient-reported quality of life to inform a larger definitive trial. Key eligibility includes documented AF, elevated NT-proBNP according to screening criteria, and stable guideline-directed medical therapy and diuretic dosing. The trial is run at the QEII Health Sciences Centre in Halifax, Nova Scotia, with oversight from the Nova Scotia Health Authority and the Heart and Stroke Foundation of Canada.

Why it matters

Who can join: the full rules

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's running

• Qeii Hsc
  Halifax, Nova Scotia, Canada Recruiting
• Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting
• London Health Sciences Centre
  London, Ontario, Canada Recruiting
• Montreal Heart Institute
  Montreal, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Laura Hamilton, BSC, MAHSR
• Email: laura.hamilton@nshealth.ca
• Phone: 902-473-7226

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.