Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
NCT ID: NCT01477528
Last Updated: 2022-06-24
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
201 participants
OBSERVATIONAL
2011-11-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Patient has signed an informed consent for data collection.
* Patient was discharged, or is being discharged, from the hospital after their initial LVAD implant surgery.
* Patient:
* at time of enrolling in study, is currently on, with the intention of being maintained on reduced anti-thrombotic therapy (RT) for chronic long-term management.
OR
\-- On or after January 1, 2011 patient was being maintained on, or had been initiated with the intention of being maintained on, reduced anti-thrombotic therapy (RT) for chronic long-term management; but where RT was subsequently discontinued due to an adverse event or transplant, explant, or death.
Exclusion Criteria
* Patients requiring a legal representative to sign consent form, rather than themselves.
* Patient is being managed on other anti-thrombotic agents
ALL
No
Sponsors
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Thoratec Europe Ltd
INDUSTRY
Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Pooja Chatterjee
Role: STUDY_DIRECTOR
Thoratec Europe Limited
David Farrar, PhD
Role: STUDY_DIRECTOR
Thoratec Corporation
Locations
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Sharp Memorial Hospital
San Diego, California, United States
University of Florida (Shands)
Gainesville, Florida, United States
Advocate Christ Hospital
Oak Lawn, Illinois, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
University of Minnesota
Minneapolis, Minnesota, United States
Columbia University Medical Center
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Medical University of Vienna
Vienna, , Austria
IKEM
Prague, , Czechia
Service de Chirurgie Cardiaque
Grenoble, , France
Hopital Cardiologique
Lille, , France
Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere
Paris, , France
Hôpital Pontchaillou
Rennes, , France
Charles Nicolle University Hospital
Rouen, , France
University of Freiburg Medical Center
Freiburg im Breisgau, , Germany
Medical University Hannover
Hanover, , Germany
Countries
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Other Identifiers
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TC-081611
Identifier Type: -
Identifier Source: org_study_id
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