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| Name | Class |
|---|---|
| Casa Sollievo della Sofferenza IRCCS | OTHER |
| Catholic University, Italy | OTHER |
| Southlake Health | OTHER |
| Stanford University |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Amiodarone | Active Comparator | Amiodarone is taken orally on a daily basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atrial Fibrillation ablation | Procedure | Radio-frequency catheter ablation of atrial fibrillation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Recurrence of AF lasting longer than 15 seconds | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in distance walked in 6-minute walk test | 1 year | |
| Total number of hospitalizations during the trial period for each group | 1 year | |
| Change in MLHF Quality of Life during trial period |
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Inclusion Criteria:
Exclusion Criteria:
The exclusion criteria are:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Natale, MD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Luigi Di Biase, MD, PhD | Texas Cardiac Arrhythmia Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78758 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27029350 | Derived | Di Biase L, Mohanty P, Mohanty S, Santangeli P, Trivedi C, Lakkireddy D, Reddy M, Jais P, Themistoclakis S, Dello Russo A, Casella M, Pelargonio G, Narducci ML, Schweikert R, Neuzil P, Sanchez J, Horton R, Beheiry S, Hongo R, Hao S, Rossillo A, Forleo G, Tondo C, Burkhardt JD, Haissaguerre M, Natale A. Ablation Versus Amiodarone for Treatment of Persistent Atrial Fibrillation in Patients With Congestive Heart Failure and an Implanted Device: Results From the AATAC Multicenter Randomized Trial. Circulation. 2016 Apr 26;133(17):1637-44. doi: 10.1161/CIRCULATIONAHA.115.019406. Epub 2016 Mar 30. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000638 | Amiodarone |
| ID | Term |
|---|---|
| D001572 | Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| OTHER |
| University of Kansas | OTHER |
| The University of Texas Medical Branch, Galveston | OTHER |
| University of Foggia | OTHER |
| Sutter Health | OTHER |
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| Amiodarone | Drug | Taken orally on a daily basis. |
|
| 1 year |
| Change in EF during trial period | 1 year |