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

Phase 4

Completed

Conditions: Post-Operative Atrial Fibrillation

Interventions: Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Drug: Anticoagulation Therapy

Registration Number: NCT02701062

Lead Sponsor: AtriCure, Inc.

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 562

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAA Exclusion with AtriClip®	AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems	LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
Medical Management	Anticoagulation Therapy	Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.

Primary Outcome Measures

Name	Time	Method
Number of Perioperative Complications Associated With AtriClip Placement	Within any 24 hour period during the first 2 days post-index procedure	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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Intraoperative Successful Exclusion of LAA.	Intraoperative period	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.
Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)	365 days post index procedure	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.
Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days	365 Days Post-Procedure	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.
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)	365 Days Post-Procedure	Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)	365 Days Post-Procedure	Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)	365 Days Post-Procedure	Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.
Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)	30 days Post-Procedure	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.

Trial Locations

Locations (22): University of Maryland
🇺🇸
Baltimore, Maryland, United States
United Heart & Vascular Clinic
🇺🇸
Saint Paul, Minnesota, United States
Cardiology Associates Research
🇺🇸
Tupelo, Mississippi, United States
University of Kansas Hospital
🇺🇸
Kansas City, Kansas, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Emory St Joseph Hospital
🇺🇸
Atlanta, Georgia, United States
Sharp Memorial Hospital
🇺🇸
San Diego, California, United States
Orlando Health Heart Institute
🇺🇸
Orlando, Florida, United States
Stanford University
🇺🇸
Stanford, California, United States
St. Vincent Heart Center, Inc.
🇺🇸
Indianapolis, Indiana, United States
St Francis Heart Hospital
🇺🇸
Indianapolis, Indiana, United States
NYU Langone Medical Center
🇺🇸
New York, New York, United States
Mount Sinai -St. Luke's
🇺🇸
New York, New York, United States
The Christ Hospital -Linder Research Center
🇺🇸
Cincinnati, Ohio, United States
Tri-Health
🇺🇸
Cincinnati, Ohio, United States
Wellmont CVA Heart Institute
🇺🇸
Kingsport, Tennessee, United States
Oregon Health and Science University
🇺🇸
Portland, Oregon, United States
Cardiovascular Surgery Clinic
🇺🇸
Memphis, Tennessee, United States
PinnacleHealth Hospitals
🇺🇸
Harrisburg, Pennsylvania, United States
Swedish Medical Center/Cherry Hill Campus
🇺🇸
Seattle, Washington, United States
Valley Health System
🇺🇸
Winchester, Virginia, United States
Aspirus Wausau Hospital
🇺🇸
Wausau, Wisconsin, United States