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

Completed

Conditions studied: Anticoagulation, Left Ventricular Assist Device

In brief

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.

Key facts

Study ID

NCT01477528

Run by

Abbott Medical Devices

People needed

201

Starts

2011-11-01

Expected to finish

2015-08-01

Last updated by the study team

2022-06-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.