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

NCT02701062 | Completed Phase 4 Results FDA Device

• 1 other identifier: CP2015-2
• Study Type: interventional
• Target: 562
• Locations: 1 country
• Sites: 22

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.

Conditions

Post-Operative Atrial Fibrillation

Keywords

Left Atrial Appendage; Anticoagulation; CHA2DS2- VASc; HASBLED

Outcome Measures

Primary Outcomes (1)

• 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.

  Within any 24 hour period during the first 2 days post-index procedure

Secondary Outcomes (7)

• Number of Subjects With Intraoperative Successful Exclusion of LAA.

  Intraoperative period

• Composite Event Rates Between Subjects Diagnosed With Post-operative Atrial Fibrillation (POAF) (Through 365 Days)

  365 days post index procedure

• Composite Event Rates Between Subjects Not Diagnosed With POAF (Through 30 Days)

  30 days Post-Procedure

• Composite Event Rates for ALL Subjects Regardless of POAF Through 365 Days

  365 Days Post-Procedure

• Healthcare Resource Utilization Variance Between Groups as Related to the Composite Events Above (Mean Values)

  365 Days Post-Procedure

Study Arms (2)

LAA Exclusion with AtriClip®

OTHER

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

Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems

Medical Management

ACTIVE COMPARATOR

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

Drug: Anticoagulation Therapy

Interventions

AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems DEVICE

Also known as: AtriClip FLEX (ACH2), AtriClip Long (LAA), AtriClip Standard (ACH1)

LAA Exclusion with AtriClip®

Anticoagulation Therapy DRUG

Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.

Also known as: Warfarin/Coumadin, New oral anticoagulants (NOACs): dabigatran, rivaroxaban, apixaban

Medical Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• AtriCure, Inc.: lead

Study Sites (22)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Stanford University

Stanford, California, 94304, United States

Location

Orlando Health Heart Institute

Orlando, Florida, 32806, United States

Location

Emory St Joseph Hospital

Atlanta, Georgia, 30308, United States

Location

St Francis Heart Hospital

Indianapolis, Indiana, 46237, United States

Location

St. Vincent Heart Center, Inc.

Indianapolis, Indiana, 46290, United States

Location

University of Kansas Hospital

Kansas City, Kansas, 66160, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

United Heart & Vascular Clinic

Saint Paul, Minnesota, 55102, United States

Location

Cardiology Associates Research

Tupelo, Mississippi, 38801, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Mount Sinai -St. Luke's

New York, New York, 10025, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

The Christ Hospital -Linder Research Center

Cincinnati, Ohio, 45219, United States

Location

Tri-Health

Cincinnati, Ohio, 45220, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

PinnacleHealth Hospitals

Harrisburg, Pennsylvania, 17101, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Cardiovascular Surgery Clinic

Memphis, Tennessee, 38120, United States

Location

Valley Health System

Winchester, Virginia, 22601, United States

Location

Swedish Medical Center/Cherry Hill Campus

Seattle, Washington, 98122, United States

Location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

MeSH Terms

Interventions

Anticoagulation Bridge; Warfarin; Rivaroxaban; apixaban

Intervention Hierarchy (Ancestors)

Bridge Therapy; Therapeutics; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines

Limitations and Caveats

ATLAS was an exempt post-market study therefore the use of oral anticoagulants could not be directed or standardized across the study sites. This led to a wide variation to the medical post-operative management in both the types drugs used for oral anticoagulation and dosage prescribed. Furthermore, the sample size for this feasibility study is relatively small to allow for a definitive conclusion on the impact of LAA occlusion and thromboembolic events.

Results Point of Contact

• Title: Nfii Ndikintum, VP Clinical Affairs and Biometrics
• Organization: AtriCure

nndikintum@atricure.com

(513) 644-8192

Study Officials

• Sydney Gaynor, MD

  AtriCure, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 8, 2016
• Study Start: February 1, 2016
• Primary Completion: April 26, 2019
• Study Completion: June 1, 2019
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)