AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery (EXCLUDE)

AtriCure

Status and phase: Completed; Phase 2

Conditions: Left Atrial Appendage Exclusion

Treatments: Device: AtriCure LAA Exclusion System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00779857

CP2008-2

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

AtriCure LAA Exclusion System

Experimental group

Description:

AtriCure LAA Exclusion System

Treatment:

Device: AtriCure LAA Exclusion System