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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02701062
Recruitment Status : Completed
First Posted : March 8, 2016
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Description
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Brief Summary:
Patients without a documented history of AF and will undergo a valve or CABG procedure with direct visual access to the LAA will be eligible to participate. Patients enrolled will be randomized 2:1 (2 with AtriClip to 1 without AtriClip. Subjects who develop POAF and receive the AtriClip will be followed for 365 days post index procedure.

Condition or disease Intervention/treatment Phase
Post-Operative Atrial Fibrillation Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems Drug: Anticoagulation Therapy Phase 4

Detailed Description:
Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 2 and HASBLED 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 562 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Study Start Date : February 2016
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
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 Name: Warfarin, Coumadin


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects with perioperative complications associated with AtriClip placement [ Time Frame: Within any 24 hour period during the first 2 days post-index procedure ]
    Defined as stroke, major bleeding, myocardial infarction, or death.


Secondary Outcome Measures :
  1. Number of subjects with intraoperative successful exclusion of LAA. [ Time Frame: 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.

  2. Number of subjects with composite event rates between the group of subjects diagnosed with POAF [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701062


Locations
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Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Study Chair: Sydney Gaynor, MD AtriCure, Inc.
More Information
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02701062    
Other Study ID Numbers: CP2015-2
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Warfarin
Anticoagulants