AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
NCT ID: NCT02701062
Last Updated: 2021-11-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
562 participants
INTERVENTIONAL
2016-02-29
2019-06-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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LAA Exclusion with AtriClip®
LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Medical Management
Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.
Anticoagulation Therapy
Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
Interventions
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AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Anticoagulation Therapy
Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years male or female.
* Scheduled for any non-mechanical valve and/or CABG (structural heart) procedure where direct access to the LAA is expected.
* No documented preoperative AF.
* CHA2DS2-VASc score of =\> 2.
* HASBLED score of =\> 2.
* Acceptable surgical candidate, including use of general anesthesia.
* Willing and able to provide written informed consent.
Exclusion Criteria
* Redo cardiac surgery.
* Mechanical heart valve or other anticipated or current requirement for anticoagulation therapy during the post-operative (30 day) period.
* Hypercoagulability conditions that may confound the study.
* Ejection Fraction \< 30.
* Left Atrium \> 6 cm.
* Severe Diastolic Dysfunction.
* Requires anticoagulation therapy.
* Patient had a stroke/cerebrovascular accident (CVA) within previous 30 days prior to signing informed consent.
* Presence of thrombus in the left atrium or LAA.
* LAA tissue is deemed friable or has significant adhesions (as evaluated by the surgeon) near or on the LAA making AtriClip placement overly risky.
* Left atrial appendage is outside the range of manufacturer's recommendations - width \< 29mm or \> 50mm.
* Direct visualization access is not available for AtriClip placement.
18 Years
ALL
No
Sponsors
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AtriCure, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sydney Gaynor, MD
Role: STUDY_CHAIR
AtriCure, Inc.
Locations
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Sharp Memorial Hospital
San Diego, California, United States
Stanford University
Stanford, California, United States
Orlando Health Heart Institute
Orlando, Florida, United States
Emory St Joseph Hospital
Atlanta, Georgia, United States
St Francis Heart Hospital
Indianapolis, Indiana, United States
St. Vincent Heart Center, Inc.
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
United Heart & Vascular Clinic
Saint Paul, Minnesota, United States
Cardiology Associates Research
Tupelo, Mississippi, United States
NYU Langone Medical Center
New York, New York, United States
Mount Sinai -St. Luke's
New York, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
The Christ Hospital -Linder Research Center
Cincinnati, Ohio, United States
Tri-Health
Cincinnati, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
PinnacleHealth Hospitals
Harrisburg, Pennsylvania, United States
Wellmont CVA Heart Institute
Kingsport, Tennessee, United States
Cardiovascular Surgery Clinic
Memphis, Tennessee, United States
Valley Health System
Winchester, Virginia, United States
Swedish Medical Center/Cherry Hill Campus
Seattle, Washington, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP2015-2
Identifier Type: -
Identifier Source: org_study_id