Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
Phase 4
Completed
- Conditions
- Heart Failure
- Interventions
- Procedure: Atrial Fibrillation ablation
- Registration Number
- NCT00729911
- Lead Sponsor
- Texas Cardiac Arrhythmia Research Foundation
- Brief Summary
1. 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.
2. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AF ablation Atrial Fibrillation ablation 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. Amiodarone Amiodarone Amiodarone is taken orally on a daily basis.
- Primary Outcome Measures
Name Time Method Time to Recurrence of AF lasting longer than 15 seconds 1 year
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Texas Cardiac Arrhythmia Research Foundation
🇺🇸Austin, Texas, United States