Catheter Ablation Versus Medical Treatment of AF in Heart Failure
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Difference in ejection fraction between groups
Study Overview
Brief Summary
Heart failure and atrial fibrillation (AF) often coexist, and each increases the morbidity and mortality associated with the other. The investigators hypothesized that restoration of normal sinus rhythm by catheter ablation is superior to medical treatment of AF in heart failure. This study randomizes patients with heart failure and persistent AF to medical treatment of AF or catheter ablation to restore sinus rhythm.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persistent atrial fibrillation
- •Symptomatic heart failure
Exclusion Criteria
- •Reversible causes of heart failure
- •Contraindications to catheter ablation
Arms & Interventions
Catheter Ablation
Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm.
Intervention: Catheter ablation of persistent atrial fibrillation (Procedure)
Medical treatment alone
Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).
Intervention: Medical treatment alone (Drug)
Outcomes
Primary Outcomes
Difference in ejection fraction between groups
Time Frame: 6 months
Difference in left ventricular ejection fraction between groups on echocardiography at 6 months
Secondary Outcomes
- Difference in peak VO2 between groups(6 months)
- Difference in NYHA class between groups(6 months)
- Difference in BNP between groups(6 months)
- Difference in Quality of Life between groups(6 months)
- Reduction in end systolic volume(6 months compared to baseline)
- Difference in heart failure symptoms(6 months)