Clinical trial NCT00779857: AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery
Official title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Left Atrial Appendage Exclusion
Keywords: left atrial appendage
laa
atrial fibrillation
afib
af
stroke
tia
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Rate of Device Related Serious Adverse Events
timeFrame: Discharge/30 days Post Procedure
measure: Percent of Patients With Complete Occlusion of the Left Atrial Appendage.
timeFrame: 3 Months Post Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Macon
country: United States
facility: Macon Medical Center
state: Georgia
city: Indianapolis
country: United States
facility: St. Francis Heart Hospital
state: Indiana
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Columbus
country: United States
facility: Mount Carmel East Hospital
state: Ohio
city: Plano
country: United States
facility: Baylor Heart Hospital
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Baylor Heart Hospital
name: Michael Mack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ailawadi G, Gerdisch MW, Harvey RL, Hooker RL, Damiano RJ Jr, Salamon T, Mack MJ. Exclusion of the left atrial appendage with a novel device: early results of a multicenter trial. J Thorac Cardiovasc Surg. 2011 Nov;142(5):1002-9, 1009.e1. doi: 10.1016/j.jtcvs.2011.07.052. Epub 2011 Sep 8.