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| Sponsor: | Texas Cardiac Arrhythmia Research Foundation |
|---|---|
| Collaborators: |
Casa Sollievo della Sofferenza IRCCS Catholic University, Italy Southlake Regional Health Centre Stanford University University of Kansas The University of Texas, Galveston University of Foggia Sutter Health |
| Information provided by: | Texas Cardiac Arrhythmia Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00729911 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Heart Failure |
Procedure: Atrial Fibrillation ablation Drug: Amiodarone |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
| Official Title: | Ablation vs. Amiodarone for Treatment of Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted ICD/CRTD |
| Estimated Enrollment: | 120 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | August 2011 |
| Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned 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. |
Procedure: Atrial Fibrillation ablation
Radio-frequency catheter ablation of atrial fibrillation
|
|
Amiodarone: Active Comparator
Amiodarone is taken orally on a daily basis.
|
Drug: Amiodarone
Taken orally on a daily basis.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The exclusion criteria are:
Contacts and Locations| Contact: Luigi Di Biase | 216-773-3879 | Luigi.Dibiase@stdavids.com |
| Contact: Deb Cardinal | 512-458-9410 | dscardinal@austinheartbeat.com |
| United States, Texas | |
| Texas Cardiac Arrhythmia Research Foundation | Recruiting |
| Austin, Texas, United States, 78758 | |
| Contact: Andrea Natale 512-458-9410 dscardinal@austinheartbeat.com | |
| Principal Investigator: | Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation |
More Information
| Responsible Party: | Texas Cardiac Arrhythmia Research Foundation ( Texas Cardiac Arrhythmia Research Foundation ) |
| Study ID Numbers: | AATAC-AF |
| Study First Received: | August 6, 2008 |
| Last Updated: | October 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00729911 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Atrial fibrillation Ablation |
|
Vasodilator Agents Heart Failure Heart Diseases Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Cardiovascular Agents Amiodarone |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Cardiovascular Diseases Atrial Fibrillation Anti-Arrhythmia Agents Arrhythmias, Cardiac |