AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation (A)
This study has been withdrawn prior to enrollment.
First Posted: November 5, 2008
Last Update Posted: February 21, 2011
Information provided by:
ABLATE Persistent is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating persistent atrial fibrillation during concomitant on-pump cardiac surgery.
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by AtriCure, Inc.:
Primary Outcome Measures:
- The primary efficacy endpoint for this study is the percent of patients free from AF and off Class I and III antiarrhythmic drugs at 9 months.
- The primary safety endpoint is the composite acute major adverse event rate, within 30 days post-procedure or hospital discharge
Secondary Outcome Measures:
- The secondary efficacy endpoint for this study is the percent of patients free from AF, independent of antiarrhythmic drug status at 9 months
- The secondary safety endpoint is the composite 9-month post-procedure major adverse event rate.
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