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

• ClinicalTrials.gov Identifier: NCT02701062
• Recruitment Status: Completed
• First Posted: March 8, 2016
• Results First Posted: November 24, 2021
• Last Update Posted: November 24, 2021
• Sponsor: AtriCure, Inc.
• Information provided by (Responsible Party): AtriCure, Inc.

Tracking Information

• First Submitted Date: February 22, 2016
• First Posted Date: March 8, 2016
• Results First Submitted Date: August 26, 2021
• Results First Posted Date: November 24, 2021
• Last Update Posted Date: November 24, 2021
• Study Start Date: February 2016
• Actual Primary Completion Date: April 26, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 28, 2021)

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.

• Original Primary Outcome Measures (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 ]

Current Secondary Outcome Measures (submitted: October 28, 2021)

• 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.

Original Secondary Outcome Measures (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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
• Official Title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
• Brief Summary: 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.
• 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
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Post-Operative Atrial Fibrillation

Intervention

• 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.
  Other Names:

  • Warfarin/Coumadin
  • New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 21, 2018): 562
• Original Estimated Enrollment (submitted: March 2, 2016): 2000
• Actual Study Completion Date: June 1, 2019
• Actual Primary Completion Date: April 26, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02701062
• Other Study ID Numbers: CP2015-2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: AtriCure, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: AtriCure, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Sydney Gaynor, MD; AtriCure, Inc.

• PRS Account: AtriCure, Inc.
• Verification Date: June 2019