Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)

Abbott

Status: Completed

Conditions: Anticoagulation; Left Ventricular Assist Device

Study type: Observational

Funder types: Industry

Identifiers

NCT01477528

TC-081611

Details and patient eligibility

About

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.

Enrollment: 201 patients

Sex: All

Volunteers: No Healthy Volunteers

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