Status:
COMPLETED
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
Lead Sponsor:
Abbott Medical Devices
Collaborating Sponsors:
Thoratec Europe Ltd
Conditions:
Anticoagulation
Left Ventricular Assist Device
Eligibility:
All Genders
Brief Summary
The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic an...
Eligibility Criteria
Inclusion
- HeartMate II Left Ventricular Assist Device (LVAD) patient
- 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
- Patients under acute management of anti-thrombotic agents before a final decision on long term antithrombotic strategy.
- Patients requiring a legal representative to sign consent form, rather than themselves.
- Patient is being managed on other anti-thrombotic agents
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT01477528
Start Date
November 1 2011
End Date
August 1 2015
Last Update
June 24 2022
Active Locations (18)
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1
Sharp Memorial Hospital
San Diego, California, United States, 92123
2
University of Florida (Shands)
Gainesville, Florida, United States, 32610
3
Advocate Christ Hospital
Oak Lawn, Illinois, United States, 60453
4
Methodist Hospital of Indiana
Indianapolis, Indiana, United States, 46202