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
Last Update Posted : April 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
LAA Exclusion with AtriClip®
LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
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
- 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.
- 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.
- 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.
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.|