AtriClip® Left Atrial Appendage Exclusion Concomitant to Structural Heart Procedures (ATLAS)
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/27/2018 |
| Start Date: | February 2016 |
| End Date: | March 2020 |
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.
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.
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.
We found this trial at
23
sites
Akron, Ohio 44304
Principal Investigator: Michael Firstenberg, MD
Phone: 330-253-8196
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Donald D Thomas, MD
Phone: 503-418-8668
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Atlanta, Georgia 30308
Principal Investigator: Jeffrey Miller, MD
Phone: 678-843-6092
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Baltimore, Maryland 20742
(301) 405-1000
Principal Investigator: Murtaza Dawood, MD
Phone: 410-328-4563
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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2123 Auburn Avenue
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Principal Investigator: Mario Castillo-Sang, MD
Phone: 513-585-1777
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3219 Clifton Avenue
Cincinnati, Ohio 45220
Cincinnati, Ohio 45220
Principal Investigator: J Michael Smith, MD
Phone: 513-862-2877
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Harrisburg, Pennsylvania 17101
Principal Investigator: Mubashir Mumtaz, MD
Phone: 717-601-0300
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Indianapolis, Indiana 46237
Principal Investigator: Marc Gerdisch, MD
Phone: 317-893-1948
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Indianapolis, Indiana 46290
Principal Investigator: David Heimansohn, MD
Phone: 317-583-6115
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Kansas City, Kansas 66160
Principal Investigator: Trip Zorn, MD
Phone: 913-588-8830
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Kingsport, Tennessee 37660
Principal Investigator: Stanley Gall, MD
Phone: 423-230-5000
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Memphis, Tennessee 38120
Principal Investigator: Edward Garrett, MD
Phone: 901-747-1268
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New York, New York 10016
Principal Investigator: Deane Smith, MD
Phone: 212-263-4188
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New York, New York 10025
Principal Investigator: John Puskas, MD
Phone: 212-844-1456
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1428 Madison Ave
New York, New York 10029
New York, New York 10029
(212) 241-6500
Principal Investigator: Ahmed El-Eshmawi, MD
Phone: 212-241-8905
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Orlando, Florida 32806
Principal Investigator: Steven J Hoff, MD
Phone: 321-841-3682
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Saint Paul, Minnesota 55102
Principal Investigator: John Grehan, MD, Ph.D
Phone: 651-241-2816
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7901 Frost Street
San Diego, California 92123
San Diego, California 92123
858-939-3400
Principal Investigator: Karl Limmer, MD
Phone: 858-939-7471
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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Seattle, Washington 98122
Principal Investigator: Glen Barnhart, MD
Phone: 206-320-3294
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450 Serra Mall
Stanford, California 94305
Stanford, California 94305
(650) 723-2300
Principal Investigator: Anson M Lee, MD
Phone: 650-724-6921
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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Tupelo, Mississippi 38801
Principal Investigator: David Talton, MD
Phone: 662-377-7571
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Wausau, Wisconsin 54401
Principal Investigator: John Johnkoski, MD
Phone: 715-847-2273
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Winchester, Virginia 22601
Principal Investigator: Basel Ramlawi, MD
Phone: 540-536-4399
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