Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2014-09-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Clinical Management Recommendations
Clinical management recommendations for reducing pump thrombosis
Clinical Management Recommendations for reducing pump thrombosis
Clinical Management Recommendations for reducing pump thrombosis
Interventions
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Clinical Management Recommendations for reducing pump thrombosis
Clinical Management Recommendations for reducing pump thrombosis
Eligibility Criteria
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Inclusion Criteria
* Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD)
Exclusion Criteria
* Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome
ALL
No
Sponsors
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Thoratec Corporation
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Kartik Sundareswaran, PhD
Role: STUDY_DIRECTOR
Abbott
Locations
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Baptist Medical Center
Little Rock, Arkansas, United States
University of California, San Diego
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Sutter Memorial
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Shands Hospital at University of Florida
Gainesville, Florida, United States
Northwestern Memorial
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Jewish Hospital
Louisville, Kentucky, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic, St. Mary's
Rochester, Minnesota, United States
University of North Carolina
Chapel Hill, North Carolina, United States
The Christ Hospital
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Abington Memorial Hospital
Abington, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Memorial Hermann/UT Texas
Houston, Texas, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Countries
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References
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Jeske W, Ransom J, Katz JN, Kilic A, Lindenfeld J, Egnaczyk G, Shah P, Brieke A, Uriel N, Crandall D, Farrar DJ, Walenga JM. Enhanced Thrombin Formation in Patients With Ventricular Assist Devices Experiencing Bleeding: Insights From the Multicenter PREVENT Study. ASAIO J. 2023 Mar 1;69(3):278-283. doi: 10.1097/MAT.0000000000001790. Epub 2022 Sep 8.
Kilic A, Ransom J, Maltais S, Sun B, Entwistle JW 3rd, Bailey S, John R, Klodell CT, Gregoric I, Sheridan B, Chuang J, Farrar DJ, Sundareswaran K, Adamson R. Pump Position Impacts HeartMate II Left Ventricular Assist Device Thrombosis. ASAIO J. 2019 Mar/Apr;65(3):227-232. doi: 10.1097/MAT.0000000000000840.
Thenappan T, Stulak JM, Agarwal R, Maltais S, Shah P, Eckman P, Emani S, Katz JN, Gregoric I, Keebler ME, Uriel N, Adler E, Chuang J, Farrar DJ, Sundareswaran KS, John R. Early intervention for lactate dehydrogenase elevation improves clinical outcomes in patients with the HeartMate II left ventricular assist device: Insights from the PREVENT study. J Heart Lung Transplant. 2018 Jan;37(1):25-32. doi: 10.1016/j.healun.2017.10.017. Epub 2017 Oct 24.
Other Identifiers
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TC05232014
Identifier Type: -
Identifier Source: org_study_id
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