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

• Status: Completed
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients without a documented history of AF and will undergo a valve or CABG procedure with direct visual access to the LAA will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AtriCure, Inc.
• Treatments: Warfarin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.