Safety and Effectiveness of Left Atrial Appendage Occlusion
This study is to evaluate acute and long-term safety and effectiveness of Left atrial appendage occlusion (LAA)with the AtriCure LAA Occlusion System. This device will be applied in patients with atrial fibrillation (AF), paroxysmal, persistent and permanent, undergoing cardiac surgery with a concomitant Maze/Ablation procedure.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- Safety - Device related complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
- Efficacy - Occlusion of the LAA [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||November 2012|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Experimental: LAA Clip
AtriCure LAA Exclusion System
Device: AtriCure LAA Exclusion System
Placement of clip of LAA.