This trial is active, not recruiting.

Condition heart failure
Treatments atrial fibrillation ablation, amiodarone
Phase phase 4
Sponsor Texas Cardiac Arrhythmia Research Foundation
Collaborator Casa Sollievo della Sofferenza IRCCS
Start date October 2008
End date December 2014
Trial size 120 participants
Trial identifier NCT00729911, AATAC-AF


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(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.
atrial fibrillation ablation
Radio-frequency catheter ablation of atrial fibrillation
(Active Comparator)
Amiodarone is taken orally on a daily basis.
Taken orally on a daily basis.

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
time frame: 1 year
Total number of hospitalizations during the trial period for each group
time frame: 1 year
Change in MLHF Quality of Life during trial period
time frame: 1 year
Change in EF during trial period
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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. 7. patients receiving low dose amiodarone- <200 mg for 2 or less months 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)

Additional Information

Official title Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD
Principal investigator Andrea Natale, MD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Texas Cardiac Arrhythmia Research Foundation.