NCT00729911CompletedPhase 4
Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD
Texas Cardiac Arrhythmia Research Foundation1 site in 1 country203 target enrollmentStarted: October 2008Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- Time to Recurrence of AF lasting longer than 15 seconds
Study Overview
Brief Summary
- 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.
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
- •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)
Arms & Interventions
AF ablation
Active Comparator
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.
Intervention: Atrial Fibrillation ablation (Procedure)
Amiodarone
Active Comparator
Amiodarone is taken orally on a daily basis.
Intervention: Amiodarone (Drug)
Outcomes
Primary Outcomes
Time to Recurrence of AF lasting longer than 15 seconds
Time Frame: 1 year
Secondary Outcomes
- 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)
Investigators
Andrea Natale
Executive Medical Director
Texas Cardiac Arrhythmia Research Foundation
Study Sites (1)
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