AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

Completed · Phase 2

Conditions studied: Left Atrial Appendage Exclusion

In brief

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.

Key facts

Study ID

NCT00779857

Run by

AtriCure, Inc.

People needed

70

Starts

2008-09-01

Expected to finish

2011-10-01

Last updated by the study team

2013-06-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Macon Medical Center — Macon, Georgia, United States
• 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
• Mount Carmel East Hospital — Columbus, Ohio, United States
• Baylor Heart Hospital — Plano, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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