AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

Phase 2

Completed

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.

Recruitment & Eligibility

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.
Subject is willing and able to return for scheduled follow-up visits.

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
Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
Pregnancy or desire to get pregnant within 12-months of the study treatment
Preoperative need for an intra-aortic balloon pump or intravenous inotropes
Patients who have been treated with thoracic radiation
Patients in current chemotherapy
Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
Patients with known connective tissue disorders

Arm && Interventions

Group	Intervention	Description
AtriCure LAA Exclusion System	AtriCure LAA Exclusion System	AtriCure LAA Exclusion System

Primary Outcome Measures

Name	Time	Method
Rate of Device Related Serious Adverse Events	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.	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.

Secondary Outcome Measures

Name	Time	Method

Locations (7): St. Francis Heart Hospital
🇺🇸
Indianapolis, Indiana, United States
Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States
Washington University School of Medicine
🇺🇸
St. Louis, Missouri, United States
Macon Medical Center
🇺🇸
Macon, Georgia, United States
Mount Carmel East Hospital
🇺🇸
Columbus, Ohio, United States
Baylor Heart Hospital
🇺🇸
Plano, Texas, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States