Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
|ClinicalTrials.gov Identifier: NCT00729911|
Recruitment Status : Active, not recruiting
First Posted : August 8, 2008
Last Update Posted : April 24, 2018
- 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)|
|Estimated Enrollment :||120 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|
|Estimated Study Completion Date :||December 2018|
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 ]
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|