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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01477528
Other study ID # TC-081611
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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