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AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery (EXCLUDE)
This study is currently recruiting participants.
Verified by AtriCure, Inc., January 2009
Sponsored by: AtriCure, Inc.
Information provided by: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00779857
  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.


Condition Intervention Phase
Left Atrial Appendage Exclusion
Device: AtriCure LAA Exclusion System
Phase II

Genetics Home Reference related topics: familial atrial fibrillation
MedlinePlus related topics: Heart Surgery
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery

Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • The primary safety outcome is the rate of device related serious adverse events. [ Time Frame: Discharge/30 days ] [ Designated as safety issue: Yes ]
  • The primary efficacy outcome for this study is the percent of patients with complete occlusion of the left atrial appendage. [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AtriCure LAA Exclusion System
    Exclusion of the left atrial appendage using the AtriCure LAA Exclusion System
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00779857

Contacts
Contact: Madonna Katenkamp 1-800-401-3506 mkatenkamp@atricure.com

Locations
United States, Georgia
Macon Medical Center Recruiting
Macon, Georgia, United States, 31201
Contact: Craig Odum     478-743-9762     c.odum@maconcvi.org    
Principal Investigator: Richard Harvey, MD            
United States, Indiana
St. Francis Heart Hospital Recruiting
Indianapolis, Indiana, United States, 45237
Contact: Katherine Lawson, BSN     317-851-2582     katherine.lawson@ssfhs.org    
Principal Investigator: Marc Gerdisch, MD            
United States, Michigan
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49506
Contact: Jennifer Cannestra, BSN     616-391-2904     jennifer.cannestra@spectrum-health.org    
Contact: Julie Bishop, BSN     (616) 391-2724     julie.bishop@spectrum-health.org    
Principal Investigator: Robert Hooker, MD            
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Tracey Guthrie, RN     314-747-4404     guthriet@wustl.edu    
Principal Investigator: Jennifer Lawton, MD            
United States, Texas
Baylor Heart Hospital Recruiting
Plano, Texas, United States, 75093
Contact: Shannon Hoffman, BSN     469-814-3466     shannon.hoffman@baylorhealth.edu    
Contact: Lisa Plummer, BSN     4698143466     lisapl@baylorhealth.edu    
Principal Investigator: Michael Mack, MD            
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sandra Burks, PhD     434-243-0315     sgb2c@virginia.edu    
Principal Investigator: Gorav Ailawadi, MD            
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Michael Mack, MD Baylor Heart Hospital
  More Information

Responsible Party: AtriCure, Inc ( James Lucky )
Study ID Numbers: CP2008-2
Study First Received: October 23, 2008
Last Updated: January 8, 2009
ClinicalTrials.gov Identifier: NCT00779857  
Health Authority: United States: Food and Drug Administration

Keywords provided by AtriCure, Inc.:
left atrial appendage
laa
atrial fibrillation
afib
af
stroke
tia

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Atrial Fibrillation

ClinicalTrials.gov processed this record on January 14, 2009