AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS) (ATLAS)
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ClinicalTrials.gov Identifier: NCT02701062 |
Recruitment Status :
Completed
First Posted : March 8, 2016
Results First Posted : November 24, 2021
Last Update Posted : November 24, 2021
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Condition or disease | Intervention/treatment | Phase |
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Post-Operative Atrial Fibrillation | Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems Drug: Anticoagulation Therapy | Phase 4 |
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 |

Arm | Intervention/treatment |
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LAA Exclusion with AtriClip®
LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
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Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Other Names:
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Active Comparator: Medical Management
Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.
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Drug: Anticoagulation Therapy
Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
Other Names:
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- Number of 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 that requires re-operation and/or transfusion of > 2 U packed red blood cells (PRBC), myocardial infarction (MI), or death.
- 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.
- Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days) [ 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.
- Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days) [ Time Frame: 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.
- Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 365 Days Post-Procedure ]Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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

Study Chair: | Sydney Gaynor, MD | AtriCure, Inc. |
Documents provided by AtriCure, Inc.:
Responsible Party: | AtriCure, Inc. |
ClinicalTrials.gov Identifier: | NCT02701062 |
Other Study ID Numbers: |
CP2015-2 |
First Posted: | March 8, 2016 Key Record Dates |
Results First Posted: | November 24, 2021 |
Last Update Posted: | November 24, 2021 |
Last Verified: | June 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Left Atrial Appendage Anticoagulation CHA2DS2- VASc HASBLED |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Warfarin Rivaroxaban Dabigatran |
Apixaban Anticoagulants Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |