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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by AtriCure, Inc.
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.
ClinicalTrials.gov Identifier:
NCT02701062
First received: February 22, 2016
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
Patients without a documented history of AF but who present with a CHA2DS2- VASc of => 3 and HASBLED of => 3 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 20 sites and will be randomized 2:1 (2 with AtriClip to 1 anticoagulation therapy and without AtriClip). Subjects who do not develop Post-operative Atrial Fibrillation (POAF) will be followed for 30 days for safety, subjects who develop POAF will be followed for 365 days post index procedure.

Condition Intervention Phase
Post-Operative Atrial Fibrillation
Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Drug: Anticoagulation Therapy (No AtriClip®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)

Resource links provided by NLM:


Further study details as provided by AtriCure, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 2000
Study Start Date: February 2016
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LAA Exclusion with AtriClip®
LAA Exclusion with AtriClip®: AtriClip® is used per label and is not experimental.
Device: AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems
Other Names:
  • AtriClip PRO (PRO)
  • AtriClip FLEX (ACH2)
  • AtriClip Long (LAA)
  • AtriClip Standard (ACH1)
Active Comparator: Medical Management
Medical Management: Standard of Care Oral Anticoagulation Therapy at the discretion of the Investigator.
Drug: Anticoagulation Therapy (No AtriClip®)
Anticoagulation Therapy - Standard of Care at the discretion of the Investigator.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 => 3.
  • HASBLED score of => 3.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02701062

Contacts
Contact: Maria Rhoades 513-755-4561 mrhoades@atricure.com

Locations
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Chris Kohlmyer    858-939-7471      
Principal Investigator: Karl Limmer, MD         
United States, Indiana
St Francis Heart Hospital Recruiting
Indianapolis, Indiana, United States, 46237
Contact: Molly Miller    317-893-1948      
Principal Investigator: Marc Gerdisch, MD         
United States, Ohio
The Christ Hospital -Linder Research Center Recruiting
Cincinnati, Ohio, United States, 45219
Contact: David White    513-585-1777      
Contact: Deborah Garza    513-585-1777      
Principal Investigator: Mario Castillo-Sang, MD         
United States, Pennsylvania
PinnacleHealth Hospitals Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Jennifer Everhart, RN    717-782-5937      
Principal Investigator: Mubashir Mumtaz, MD         
United States, Tennessee
Wellmont CVA Heart Institute Recruiting
Kingsport, Tennessee, United States, 37660
Contact: Terrie Walker, RN    423-230-5000      
Principal Investigator: Stanley Gall, MD         
Cardiovascular Surgery Clinic Recruiting
Memphis, Tennessee, United States, 38120
Contact: Amber Kirby, RN    901-747-1268      
Principal Investigator: Edward Garrett, MD         
United States, Virginia
Valley Health System Recruiting
Winchester, Virginia, United States, 22601
Contact: Stephanie Lane, RN    540-536-4399      
Principal Investigator: Basel Ramlawi, MD         
United States, Washington
Swedish Medical Center/Cherry Hill Campus Recruiting
Seattle, Washington, United States, 98122
Contact: Christine Goetz, BA    206-215-2843      
Principal Investigator: Glen Barnhart, MD         
United States, Wisconsin
Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Jennifer Burken, MS    715-847-2273 ext 52638      
Principal Investigator: John Johnkoski, MD         
Sponsors and Collaborators
AtriCure, Inc.
Investigators
Study Chair: Sydney Gaynor, MD AtriCure, Inc.
  More Information

Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT02701062     History of Changes
Other Study ID Numbers: CP2015-2 
Study First Received: February 22, 2016
Last Updated: January 26, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: To be determined

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on February 20, 2017