SHS_300309 BARG CATC 16015

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

Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 3 and HASBLED of => 3 and will undergo a valve or CABG (structural heart) procedure with direct visual access to the LAA will be eligible to participate based upon the inclusion and exclusion criteria defined in this protocol. Up to 2000 patients will enroll at up to 20 sites and will be randomized 2:1 (2 with AtriClip to 1 anticoagulation therapy and without AtriClip). Subjects who do not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety, subjects who develop POAF will be followed for 365 days post index procedure.

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 => 3.
HASBLED score of => 3.
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.

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.
Phase IV
Heart and Vascular, All Other
Glenn Barnhart, M.D.
xChristine Goetz
  • Swedish Medical Center