Anticoagulation, Left Ventricular Assist Device
Conditions
Keywords
HeartMate II, Anticoagulation, Thoratec Corporation
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 and bleeding adverse events associated with these regimes.
Interventions
None listed
Sponsors
Thoratec Europe Ltd
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of thromboembolic events and hemorrhagic events | 24 months |
Countries
Austria, Czechia, France, Germany, United States
Outcome results
None listed