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

Post-Operative Atrial Fibrillation Clinical Trial

— ATLAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02701062
• Other study ID #: CP2015-2
• Status: Completed
• Phase: Phase 4
• Start date: February 2016
• Est. completion date: June 1, 2019

Study information

• Verified date: June 2019
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 562
• Est. completion date: June 1, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Post-Operative Atrial Fibrillation

Intervention

Device:
• AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems

Drug:
• Anticoagulation Therapy
Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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