Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Left Atrial Appendage Exclusion
- Sponsor
- AtriCure, Inc.
- Enrollment
- 70
- Locations
- 7
- Primary Endpoint
- Rate of Device Related Serious Adverse Events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
Prospective, non-randomized trial to evaluate the safety and efficacy of the LAA Exclusion Device (Clip) for the exclusion of the LAA via epicardial tissue approximation.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is greater than or equal to 18 years of age.
- •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 atrial fibrillation (any classification)
- •Subject is scheduled to undergo elective non-endoscopic cardiac surgical procedure(s) including cardiac surgery for one or more of the following: Mitral valve repair or replacement, Aortic valve repair or placement, Tricuspid valve repair or replacement, Coronary artery bypass procedures, concomitant surgical (ablation or cut-and-sew) Maze procedure, patent foramen ovale (PFO), atrial septal defect (ASD) repair with the device deployed while on or prepared for cardio-pulmonary bypass support.
- •Subject is willing and able to provide written informed consent.
- •Subject has a life expectancy of at least 1 year.
Exclusion Criteria
- •Previous cardiac surgery
- •Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
- •Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
- •NYHA Class IV heart failure symptoms
- •Need for emergent cardiac surgery (i.e. cardiogenic shock)
- •Creatinine \>200 µmol/L
- •LAA is not appropriate for exclusion based on intraoperative evaluations
- •Current diagnosis of active systemic infection
- •Renal failure requiring dialysis or hepatic failure
- •A known drug and/or alcohol addiction
Outcomes
Primary Outcomes
Rate of Device Related Serious Adverse Events
Time Frame: Discharge/30 days Post Procedure
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.
Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
Time Frame: 3 Months Post Procedure
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.