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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Post-Operative Atrial Fibrillation

Intervention / Treatment
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* Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
* Drug: Anticoagulation Therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: LAA Exclusion with AtriClip®<br>LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental. | Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems<br> <br> * Other names: AtriClip Standard (ACH1);|
| Active Comparator: Medical Management<br>Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator. | Drug: Anticoagulation Therapy<br>* Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.<br>* Other names: New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Perioperative Complications Associated With AtriClip Placement | Defined as: stroke, major bleeding that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death. | Within any 24 hour period during the first 2 days post-index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Intraoperative Successful Exclusion of LAA. | Successful exclusion of LAA is defined as no (0 mm) flow between LAA and LA and < 5 mm LAA remnant by intraoperative TEE with Doppler. | Intraoperative period | 
| Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | 365 days post index procedure | 
| Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | 30 days Post-Procedure | 
| Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days | Events to be evaluated include: Thromboembolic & Hemorrhagic Events such as cerebrovascular accident (CVA), transient ischemic attack (TIA), peripheral ischemia, hemorrhagic stroke, neurologic bleed, gastrointestinal (GI) bleeds, or other major bleeding event. | 365 Days Post-Procedure | 
| Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values) | Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions. | 365 Days Post-Procedure | 
| Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values) | Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions. | 365 Days Post-Procedure | 
| Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates) | Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits. | 365 Days Post-Procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Atrial Appendage, Anticoagulation, CHA2DS2- VASc, HASBLED