AtriCure Bipolar Radiofrequency Ablation of Persistent Atrial Fibrillation (A)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00785902|
Recruitment Status : Withdrawn
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.
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: AtriCure Bipolar System||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
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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