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

AtriCure

Status and phase

Completed

Phase 4

Conditions

Post-Operative Atrial Fibrillation

Treatments

Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems

Drug: Anticoagulation Therapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT02701062

CP2015-2

Details and patient eligibility

About

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.

Full description

Patients without a documented history of AF but who present with a CHA2DS2- VASc (congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, stroke or transient ischemic attack (TIA), vascular disease, age 65 to 74 years, sex category) of => 2 and HASBLED (Hypertension, Abnormal Renal/Liver Function, Stroke, Bleeding History or Predisposition, Labile INR, Elderly, Drugs/Alcohol Concomitantly) of => 2 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 40 sites and will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety. Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.

Enrollment

562 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.