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

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ClinicalTrials.gov Identifier: NCT02701062
Recruitment Status : Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Tracking Information
First Submitted Date  ICMJE February 22, 2016
First Posted Date  ICMJE March 8, 2016
Last Update Posted Date September 25, 2018
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02701062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2016)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Official Title  ICMJE AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Post-Operative Atrial Fibrillation
Intervention  ICMJE
  • Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
    Other Names:
    • AtriClip FLEX (ACH2)
    • AtriClip Long (LAA)
    • AtriClip Standard (ACH1)
  • Drug: Anticoagulation Therapy
    Anticoagulation Therapy - Standard of Care at the discretion of the Investigator.
Study Arms  ICMJE
  • LAA Exclusion with AtriClip®
    LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
    Intervention: 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.
    Intervention: Drug: Anticoagulation Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 21, 2018)
562
Original Estimated Enrollment  ICMJE
 (submitted: March 2, 2016)
2000
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02701062
Other Study ID Numbers  ICMJE CP2015-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: To be determined
Responsible Party AtriCure, Inc.
Study Sponsor  ICMJE AtriCure, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Sydney Gaynor, MD AtriCure, Inc.
PRS Account AtriCure, Inc.
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP