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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT00779857
First received: October 23, 2008
Last updated: May 31, 2013
Last verified: May 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • Rate of Device Related Serious Adverse Events [ Time Frame: Discharge/30 days Post Procedure ] [ Designated as safety issue: Yes ]
    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.

  • Percent of Patients With Complete Occlusion of the Left Atrial Appendage. [ Time Frame: 3 Months Post Procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: September 2008
Study Completion Date: October 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AtriCure LAA Exclusion System
AtriCure LAA Exclusion System
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00779857

Locations
United States, Georgia
Macon Medical Center
Macon, Georgia, United States, 31201
United States, Indiana
St. Francis Heart Hospital
Indianapolis, Indiana, United States, 45237
United States, Michigan
Spectrum Health
Grand Rapids, Michigan, United States, 49506
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Ohio
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
United States, Texas
Baylor Heart Hospital
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Principal Investigator: Michael Mack, MD Baylor Heart Hospital
  More Information

No publications provided by AtriCure, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT00779857     History of Changes
Other Study ID Numbers: CP2008-2
Study First Received: October 23, 2008
Results First Received: February 11, 2013
Last Updated: May 31, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 19, 2014