Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
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|ClinicalTrials.gov Identifier: NCT00729911|
Recruitment Status : Completed
First Posted : August 8, 2008
Last Update Posted : April 10, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Procedure: Atrial Fibrillation ablation Drug: Amiodarone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2015|
Active Comparator: AF 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.
Procedure: Atrial Fibrillation ablation
Radio-frequency catheter ablation of atrial fibrillation
Active Comparator: Amiodarone
Amiodarone is taken orally on a daily basis.
Taken orally on a daily basis.
- Time to Recurrence of AF lasting longer than 15 seconds [ Time Frame: 1 year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729911
|United States, Texas|
|Texas Cardiac Arrhythmia Research Foundation|
|Austin, Texas, United States, 78758|
|Principal Investigator:||Andrea Natale, MD||Texas Cardiac Arrhythmia Research Foundation|
|Principal Investigator:||Luigi Di Biase, MD, PhD||Texas Cardiac Arrhythmia Research Foundation|