AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery

Left Atrial Appendage Exclusion Clinical Trial

— EXCLUDE  

Official title:

Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00779857
• Other study ID #: CP2008-2
• Status: Completed
• Phase: Phase 2
• First received: October 23, 2008
• Last updated: May 31, 2013
• Start date: September 2008
• Est. completion date: October 2011

Study information

• Verified date: May 2013
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Left Atrial Appendage Exclusion

Intervention

Device:
• AtriCure LAA Exclusion System
Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	Mount Carmel East Hospital	Columbus	Ohio
United States	Spectrum Health	Grand Rapids	Michigan
United States	St. Francis Heart Hospital	Indianapolis	Indiana
United States	Macon Medical Center	Macon	Georgia
United States	Baylor Heart Hospital	Plano	Texas
United States	Washington University School of Medicine	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Device Related Serious Adverse Events	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.	Discharge/30 days Post Procedure	Yes
Primary	Percent of Patients With Complete Occlusion of the Left Atrial Appendage.	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.	3 Months Post Procedure	No