Status:
COMPLETED
AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Lead Sponsor:
AtriCure, Inc.
Conditions:
Left Atrial Appendage Exclusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00779857
Start Date
September 1 2008
End Date
October 1 2011
Last Update
June 4 2013
Active Locations (7)
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1
Macon Medical Center
Macon, Georgia, United States, 31201
2
St. Francis Heart Hospital
Indianapolis, Indiana, United States, 45237
3
Spectrum Health
Grand Rapids, Michigan, United States, 49506
4
Washington University School of Medicine
St Louis, Missouri, United States, 63110