Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AtriCure LAA Exclusion System · 2 trials · 2 indications
The primary safety endpoint is the rate of device related serious adverse events within 30 days post-procedure or hospital discharge, whichever is later, compared with the rates for serious adverse events for LAA exclusion reported in the peer review literature. The safety endpoint was determined based on an independent review of all reported adverse events by an independent cardiac surgeon that was not an investigator in the study.
The primary efficacy endpoint is defined as the complete exclusion of the LAA defined by lack of fluid communication between the LA and LAA at both intra-operative (TEE) and 3 month (CT) evaluations and intra-operative verification of completeness of LAA exclusion.
| Arm | Type | Description |
|---|---|---|
| AtriCure LAA Exclusion System | EXPERIMENTAL | AtriCure LAA Exclusion System |
| LAA Clip | EXPERIMENTAL | AtriCure LAA Exclusion System |
| Name | Type | Description |
|---|---|---|
| AtriCure LAA Exclusion System | DEVICE | Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System |
Inclusion Criteria: 1. Subject is greater than or equal to 18 years of age. 2. Subject has any one of the following risk factors and is thought to benefit from LAA occlusion: * CHADS score \> 2 * Age \> 75 years * Hypertension and age \> 65 years * Previous stroke * History of atria...
The AtriCure LAA Exclusion System is used for left atrial appendage exclusion in patients with atrial fibrillation. It is an investigational device being studied for its safety and effectiveness in occluding the left atrial appendage during cardiac surgery.
AtriCure, Inc. (NASDAQ: ATRC) develops the AtriCure LAA Exclusion System. The company is conducting clinical trials to evaluate the device for left atrial appendage exclusion in patients with atrial fibrillation.
The AtriCure LAA Exclusion System is in Phase 2 clinical development. It is an investigational device and has not been approved by the FDA. Two Phase 2 trials have been completed to assess its safety and effectiveness.
The AtriCure LAA Exclusion System has been studied in two completed Phase 2 trials: NCT00567515, titled 'Safety and Effectiveness of Left Atrial Appendage Occlusion' in Switzerland, and NCT00779857, titled 'AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery' in the United States.
The AtriCure LAA Exclusion System is not FDA approved. It is an investigational device currently in Phase 2 clinical development. Two clinical trials have been completed, but the device has not yet received regulatory approval.