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Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD - NCT00729911-78758(Clinical Trial 235141)



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City:  Austin
State:  
TX
Zip Code: 78758
Conditions: Heart Failure
Purpose: 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.
Study summary:
Criteria: Inclusion Criteria: 1. 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, 2. 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. 3. Therapeutic anticoagulation for at least three weeks prior to initiation of therapy 4. Ability to complete 6 minute walk test. 5. 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). 6. All patients optimized on CHF medications including beta-blocker and ace-inhibitor or angiotensin-receptor blocker. Exclusion Criteria: The exclusion criteria are: 1. Reversible causes of AF such as pericarditis, hyperthyroidism, 2. Presently with Valvular Heart disease requiring surgical intervention 3. Presently with coronary artery disease requiring surgical intervention 4. Early Post-operative AF (within three months of surgery) 5. Previous MAZE or left atrial instrumentation 6. Prolonged QT interval 7. Hypothyroidism 8. Liver Failure 9. Life expectancy <= 2 years 10. Social factors that would preclude follow up or make compliance difficult. 11. Contraindication to the use of anti-arrhythmic medications and/or coumadin and heparin 12. Enrollment in another investigational drug or device study. 13. Patients with severe pulmonary disease i.e. COPD or asthma 14. Documented intra-atrial thrombus, tumor, or another abnormality which precludes catheter introduction 15. Any ophthalmologic disorders (other than requiring glasses for vision correction)
Study is available at: Texas Cardiac Arrhythmia Research Foundation
Austin, TX 78758
United States

Primary Contact:
Andrea Natale
Email: dscardinal@austinheartbeat.com
Phone: 512-458-9410

Secondary Contact:
Luigi Di Biase
Email: Luigi.Dibiase@stdavids.com
Phone: 216-773-3879
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 22, 2011
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