AtriCure Exclusion of the LAA in Patients Undergoing Concomitant Cardiac Surgery (EXCLUDE)
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|ClinicalTrials.gov Identifier: NCT00779857|
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : June 4, 2013
Last Update Posted : June 4, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Left Atrial Appendage Exclusion||Device: AtriCure LAA Exclusion System||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exclusion of the Left Atrial Appendage With the AtriClip LAA Exclusion Device in Patients Undergoing Concomitant Cardiac Surgery|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||October 2009|
|Actual Study Completion Date :||October 2011|
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
- Rate of Device Related Serious Adverse Events [ Time Frame: Discharge/30 days Post Procedure ]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 ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subject is greater than or equal to 18 years of age.
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)
- 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.
- Subject is willing and able to provide written informed consent.
- Subject has a life expectancy of at least 1 year.
- Subject is willing and able to return for scheduled follow-up visits.
- Previous cardiac surgery
- Thrombus in the LAA/LA which cannot be evacuated prior to placement of the Clip.
- Patients requiring surgery other than CABG and/or cardiac valve and/or surgical maze procedure and/or PFO closure and/or ASD repair.
- NYHA Class IV heart failure symptoms
- Need for emergent cardiac surgery (i.e. cardiogenic shock)
- Creatinine >200 µmol/L
- LAA is not appropriate for exclusion based on intraoperative evaluations
- Current diagnosis of active systemic infection
- Renal failure requiring dialysis or hepatic failure
- A known drug and/or alcohol addiction
- Mental impairment or other conditions which may not allow the subject to understand the nature, significance and scope of the study
- Pregnancy or desire to get pregnant within 12-months of the study treatment
- Preoperative need for an intra-aortic balloon pump or intravenous inotropes
- Patients who have been treated with thoracic radiation
- Patients in current chemotherapy
- Patients on long term treatment with steroids not including intermittent use of inhaled steroids for respiratory diseases.
- Patients with known connective tissue disorders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779857
|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|
|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|
|Principal Investigator:||Michael Mack, MD||Baylor Heart Hospital|
|Responsible Party:||AtriCure, Inc.|
|Other Study ID Numbers:||
|First Posted:||October 24, 2008 Key Record Dates|
|Results First Posted:||June 4, 2013|
|Last Update Posted:||June 4, 2013|
|Last Verified:||May 2013|
left atrial appendage