Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Not Applicable

• Conditions: Atrial Fibrillation; Heart Failure
• Interventions: Procedure: Catheter ablation of persistent atrial fibrillation; Drug: Medical treatment alone

• Registration Number: NCT01411371
• Lead Sponsor: Barts & The London NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03
• Status Verified: 2010-05
• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2011-08-05
• Last Update Submitted: 2011-08-05
• Study First Posted: 2011-08-08
• Last Update Posted: 2011-08-08
• Primary Completion: 2011-10
• Study Completion: 2011-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Persistent atrial fibrillation
• Symptomatic heart failure

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Exclusion Criteria

• Reversible causes of heart failure
• Contraindications to catheter ablation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter Ablation	Catheter ablation of persistent atrial fibrillation	Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm.
Medical treatment alone	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).

Primary Outcome Measures

Name	Time	Method
Difference in ejection fraction between groups	6 months	Difference in left ventricular ejection fraction between groups on echocardiography at 6 months

Secondary Outcome Measures

Name	Time	Method
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	Using SF36 and Minnessota questionaire
Reduction in end systolic volume	6 months compared to baseline	Comparisson between groups of the percentage reduction in left ventricular end systolic volume at 6 months compared to baseline.
Difference in heart failure symptoms	6 months	Comparisson between groups in heart failure symptoms using the Minessota living with heart failure questionaire.

Trial Locations

Locations (1)

Barts & The London NHS Trust; 🇬🇧 London, UK, United Kingdom