AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

Completed · Phase 4

Conditions studied: Post-Operative Atrial Fibrillation

In brief

Patients without a documented history of Atrial Fibrillation (AF) and will undergo a valve or Coronary Artery Bypass Graft (CABG) procedure with direct visual access to the Left Atrial Appendage (LAA) will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop Post-operative Atrial Fibrillation (POAF) and receive the AtriClip will be followed for 365 days post index procedure.

Key facts

Study ID

NCT02701062

Run by

AtriCure, Inc.

People needed

562

Starts

2016-02-01

Expected to finish

2019-06-01

Last updated by the study team

2021-11-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients satisfying the following criteria will be considered the screening population and will be eligible for participation:
• 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.

You may not qualify if…

• Patients satisfying the following criteria will not be eligible for participation:
• 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.
• Intra-Operative Exclusion Criteria
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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