Expired Study
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Indianapolis, Indiana 45237


Purpose:

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.


Criteria:

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 atrial fibrillation (any classification) 3. 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. 4. Subject is willing and able to provide written informed consent. 5. Subject has a life expectancy of at least 1 year. 6. Subject is willing and able to return for scheduled follow-up visits. Exclusion Criteria: 1. Previous cardiac surgery 2. Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip. 3. Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair. 4. NYHA Class IV heart failure symptoms 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) 6. Creatinine >200 µmol/L 7. LAA is not appropriate for exclusion based on intraoperative evaluations 8. Current diagnosis of active systemic infection 9. Renal failure requiring dialysis or hepatic failure 10. A known drug and/or alcohol addiction 11. Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study 12. Pregnancy or desire to get pregnant within 12-months of the study treatment 13. Preoperative need for an intra-aortic balloon pump or intravenous inotropes 14. Patients who have been treated with thoracic radiation 15. Patients in current chemotherapy 16. Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases. 17. Patients with known connective tissue disorders


NCT ID:

NCT00779857


Primary Contact:

Principal Investigator
Michael Mack, MD
Baylor Heart Hospital


Backup Contact:

N/A


Location Contact:

Indianapolis, Indiana 45237
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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