drugset / Trial / NCT00729911
Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
Phase 4
Completed
203 enrolled
Texas Cardiac Arrhythmia Research Foundation
Casa Sollievo della Sofferenza IRCCS · collabCatholic University, Italy · collabSouthlake Health · collabStanford University · collabSutter Health · collabThe University of Texas Medical Branch, Galveston · collabUniversity of Foggia · collabUniversity of Kansas · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2008-10
- Primary completion
- 2014-12
- Completion
- 2015-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Amiodarone | Small molecule | — | Oral |