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

Anticoagulation Clinical Trial

— TRACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477528
• Other study ID #: TC-081611
• Status: Completed
• Start date: November 2011
• Est. completion date: August 2015

Study information

• Verified date: June 2022
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulation
• Left Ventricular Assist Device

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna
Czechia	IKEM	Prague
France	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
Germany	University of Freiburg Medical Center	Freiburg
Germany	Medical University Hannover	Hannover
United States	University of North Carolina	Chapel Hill	North Carolina
United States	University of Florida (Shands)	Gainesville	Florida
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	Advocate Christ Hospital	Oak Lawn	Illinois
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Sharp Memorial Hospital	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Thoratec Europe Ltd

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of thromboembolic events and hemorrhagic events		24 months