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

Primary Purpose

Post-Operative Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Anticoagulation Therapy
Sponsored by
AtriCure, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Post-Operative Atrial Fibrillation focused on measuring Left Atrial Appendage, Anticoagulation, CHA2DS2- VASc, HASBLED

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sharp Memorial Hospital
  • Stanford University
  • Orlando Health Heart Institute
  • Emory St Joseph Hospital
  • St Francis Heart Hospital
  • St. Vincent Heart Center, Inc.
  • University of Kansas Hospital
  • University of Maryland
  • United Heart & Vascular Clinic
  • Cardiology Associates Research
  • NYU Langone Medical Center
  • Mount Sinai -St. Luke's
  • Icahn School of Medicine at Mount Sinai
  • The Christ Hospital -Linder Research Center
  • Tri-Health
  • Oregon Health and Science University
  • PinnacleHealth Hospitals
  • Wellmont CVA Heart Institute
  • Cardiovascular Surgery Clinic
  • Valley Health System
  • Swedish Medical Center/Cherry Hill Campus
  • Aspirus Wausau Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

LAA Exclusion with AtriClip®

Medical Management

Arm Description

LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.

Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.

Outcomes

Primary Outcome Measures

Number of Perioperative Complications Associated With AtriClip Placement
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.

Secondary Outcome Measures

Number of Subjects With Intraoperative Successful Exclusion of LAA.
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)
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)
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
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)
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)
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)
Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.

Full Information

First Posted
February 22, 2016
Last Updated
October 28, 2021
Sponsor
AtriCure, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02701062
Brief Title
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Acronym
ATLAS
Official Title
AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
April 26, 2019 (Actual)
Study Completion Date
June 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AtriCure, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Operative Atrial Fibrillation
Keywords
Left Atrial Appendage, Anticoagulation, CHA2DS2- VASc, HASBLED

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
562 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LAA Exclusion with AtriClip®
Arm Type
Other
Arm Description
LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
Arm Title
Medical Management
Arm Type
Active Comparator
Arm Description
Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.
Intervention Type
Device
Intervention Name(s)
AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Other Intervention Name(s)
AtriClip FLEX (ACH2), AtriClip Long (LAA), AtriClip Standard (ACH1)
Intervention Type
Drug
Intervention Name(s)
Anticoagulation Therapy
Other Intervention Name(s)
Warfarin/Coumadin, New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban
Intervention Description
Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
Primary Outcome Measure Information:
Title
Number of Perioperative Complications Associated With AtriClip Placement
Description
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.
Time Frame
Within any 24 hour period during the first 2 days post-index procedure
Secondary Outcome Measure Information:
Title
Number of Subjects With Intraoperative Successful Exclusion of LAA.
Description
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.
Time Frame
Intraoperative period
Title
Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)
Description
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.
Time Frame
365 days post index procedure
Title
Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)
Description
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.
Time Frame
30 days Post-Procedure
Title
Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days
Description
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.
Time Frame
365 Days Post-Procedure
Title
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)
Description
Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Time Frame
365 Days Post-Procedure
Title
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Median Values)
Description
Healthcare resource utilization variance between groups as related to hospital length-of-stay (LOS) and hospital readmissions.
Time Frame
365 Days Post-Procedure
Title
Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Event Rates)
Description
Specifically, reoperation for bleeding, neurologic consults for stroke or TIA, and emergency department (ED) visits.
Time Frame
365 Days Post-Procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sydney Gaynor, MD
Organizational Affiliation
AtriCure, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Orlando Health Heart Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory St Joseph Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
St Francis Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St. Vincent Heart Center, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
United Heart & Vascular Clinic
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Cardiology Associates Research
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai -St. Luke's
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
The Christ Hospital -Linder Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Tri-Health
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
PinnacleHealth Hospitals
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17101
Country
United States
Facility Name
Wellmont CVA Heart Institute
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Cardiovascular Surgery Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Valley Health System
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Swedish Medical Center/Cherry Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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