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

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.

Study Overview

• Status: Completed
• Conditions: Post-Operative Atrial Fibrillation
• Intervention / Treatment: Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems; Drug: Anticoagulation Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 562
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Sharp Memorial Hospital
    • Stanford, California, United States, 94304
      • Stanford University
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Heart Institute
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory St Joseph Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46237
      • St Francis Heart Hospital
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center, Inc.
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Minnesota
    • Saint Paul, Minnesota, United States, 55102
      • United Heart & Vascular Clinic
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Cardiology Associates Research
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10025
      • Mount Sinai -St. Luke's
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Christ Hospital -Linder Research Center
    • Cincinnati, Ohio, United States, 45220
      • Tri-Health
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17101
      • PinnacleHealth Hospitals
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Wellmont CVA Heart Institute
    • Memphis, Tennessee, United States, 38120
      • Cardiovascular Surgery Clinic
  • Virginia
    • Winchester, Virginia, United States, 22601
      • Valley Health System
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Medical Center/Cherry Hill Campus
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LAA Exclusion with AtriClip®; LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.	Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems; Other Names: AtriClip FLEX (ACH2); AtriClip Long (LAA); AtriClip Standard (ACH1)
Active Comparator: Medical Management; Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.	Drug: Anticoagulation Therapy; Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.; Other Names: Warfarin/Coumadin; New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AtriCure, Inc.
• Investigators: Study Chair: Sydney Gaynor, MD, AtriCure, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): April 26, 2019
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 2, 2016
• First Posted (Estimate): March 8, 2016

Study Record Updates

• Last Update Posted (Actual): November 24, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Anticoagulation; Left Atrial Appendage; CHA2DS2- VASc; HASBLED
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Rivaroxaban; Dabigatran; Apixaban; Warfarin; Anticoagulants
• Other Study ID Numbers: CP2015-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes