Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD

Study Overview
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Brief Summary
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To determine if catheter-based atrial fibrillation (AF) ablation is superior to Amiodarone treatment for symptomatic persistent/permanent AF in ICD/CRTD patients with an impaired left ventricular function. Hypothesis: AF ablation is better than Amiodarone for subjects with symptomatic persistent or permanent AF and impaired LV function in terms of recurrence of AF, quality of life, 6-minute walk distance, EF and total number of hospitalizations.

Official Title
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Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD

Conditions
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Heart Failure

Intervention / Treatment
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* Procedure: Atrial Fibrillation ablation
* Drug: Amiodarone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with an dual chamber ICD or CRTD (with an existing functional atrial lead) with remote monitoring capabilities and EF <= 40% within the last 3 months by echocardiogram, nuclear imaging, MRI or cardiac catheterization, Persistent or chronic symptomatic AF resistant to anti-arrhythmic medication other than Amiodarone. Resistant defined as recurrent AF of greater than 5 minutes duration at least once per month. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy Ability to complete 6 minute walk test. Age >= 18 years old. (Females must be either post-menopausal >12 months, practicing a protocol-acceptable method of birth control [defined as injectable or implantable hormonal contraceptives, oral contraceptives, intrauterine device, diaphragm plus spermicide], or have had a hysterectomy, bilateral oophorectomy, or tubal ligation performed at least 6 months prior to enrollment). All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker. patients receiving low dose amiodarone- <200 mg for 2 or less months Exclusion Criteria: The exclusion criteria are: Reversible causes of AF such as pericarditis, hyperthyroidism, Presently with Valvular Heart disease requiring surgical intervention Presently with coronary artery disease requiring surgical intervention Early Post-operative AF (within three months of surgery) Previous MAZE or left atrial instrumentation Prolonged QT interval Hypothyroidism Liver Failure Life expectancy <= 2 years Social factors that would preclude follow up or make compliance difficult. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin Enrollment in another investigational drug or device study. Patients with severe pulmonary disease i.e. COPD or asthma Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction Any ophthalmologic disorders (other than requiring glasses for vision correction)

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 |
| --- | --- |
| Active Comparator: AF ablation<br>Subjects assigned to the catheter ablation strategy will undergo catheter based AF ablation. The goal of the procedure is to achieve isolation of all 4 pulmonary veins. Subjects assigned to receive Amiodarone will have the oral medication initiated in an clinic setting. | Procedure: Atrial Fibrillation ablation<br>* Radio-frequency catheter ablation of atrial fibrillation<br>|
| Active Comparator: Amiodarone<br>Amiodarone is taken orally on a daily basis. | Drug: Amiodarone<br>* Taken orally on a daily basis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recurrence of AF lasting longer than 15 seconds |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in distance walked in 6-minute walk test |  | 1 year | 
| Total number of hospitalizations during the trial period for each group |  | 1 year | 
| Change in MLHF Quality of Life during trial period |  | 1 year | 
| Change in EF during trial period |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation Ablation