Clinical trial NCT02701062: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Official title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-Operative Atrial Fibrillation
Keywords: Left Atrial Appendage
Anticoagulation
CHA2DS2- VASc
HASBLED
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 562
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Perioperative Complications Associated With AtriClip Placement
timeFrame: Within any 24 hour period during the first 2 days post-index procedure
Secondary outcomes:
measure: Number of Subjects With Intraoperative Successful Exclusion of LAA.
timeFrame: Intraoperative period
measure: Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
timeFrame: 365 days post index procedure
measure: Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
timeFrame: 30 days Post-Procedure
measure: Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
timeFrame: 365 Days Post-Procedure
measure: Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
timeFrame: 365 Days Post-Procedure
measure: Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
timeFrame: 365 Days Post-Procedure
measure: Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
timeFrame: 365 Days Post-Procedure
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Orlando
country: United States
facility: Orlando Health Heart Institute
state: Florida
city: Atlanta
country: United States
facility: Emory St Joseph Hospital
state: Georgia
city: Indianapolis
country: United States
facility: St Francis Heart Hospital
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Heart Center, Inc.
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Hospital
state: Kansas
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Saint Paul
country: United States
facility: United Heart & Vascular Clinic
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research
state: Mississippi
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Mount Sinai -St. Luke's
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital -Linder Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Tri-Health
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Harrisburg
country: United States
facility: PinnacleHealth Hospitals
state: Pennsylvania
city: Kingsport
country: United States
facility: Wellmont CVA Heart Institute
state: Tennessee
city: Memphis
country: United States
facility: Cardiovascular Surgery Clinic
state: Tennessee
city: Winchester
country: United States
facility: Valley Health System
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center/Cherry Hill Campus
state: Washington
city: Wausau
country: United States
facility: Aspirus Wausau Hospital
state: Wisconsin
Study officials:
affiliation: AtriCure, Inc.
name: Sydney Gaynor, MD
role: STUDY_CHAIR
References: