Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Study Overview
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Brief Summary
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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.

Official Title
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Catheter Ablation Versus Medical Treatment of AF in Heart Failure

Conditions
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Atrial Fibrillation, Heart Failure

Intervention / Treatment
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* Procedure: Catheter ablation of persistent atrial fibrillation
* Drug: Medical treatment alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persistent atrial fibrillation Symptomatic heart failure Exclusion Criteria: Reversible causes of heart failure Contraindications to catheter ablation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter Ablation<br>Catheter ablation of persistent atrial fibrillation to restore normal sinus rhythm. | Procedure: Catheter ablation of persistent atrial fibrillation<br>* Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).<br>|
| Active Comparator: Medical treatment alone<br>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). | Drug: Medical treatment alone<br>* Medical treatment of persistent AF as 'normal care'. 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in ejection fraction between groups | Difference in left ventricular ejection fraction between groups on echocardiography at 6 months | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Heart failure, Catheter ablation