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

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01477528
Collaborator
Thoratec Europe Ltd (Industry)
201
Enrollment
18
Locations
45
Duration (Months)
11.2
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    201 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Jul 1, 2015
    Actual Study Completion Date :
    Aug 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. Rate of thromboembolic events and hemorrhagic events [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sharp Memorial Hospital San Diego California United States 92123
    2 University of Florida (Shands) Gainesville Florida United States 32610
    3 Advocate Christ Hospital Oak Lawn Illinois United States 60453
    4 Methodist Hospital of Indiana Indianapolis Indiana United States 46202
    5 St. Vincent Heart Center of Indiana Indianapolis Indiana United States 46260
    6 University of Minnesota Minneapolis Minnesota United States 55455
    7 Columbia University Medical Center New York New York United States 10032
    8 University of North Carolina Chapel Hill North Carolina United States 27599
    9 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    10 Medical University of Vienna Vienna Austria
    11 IKEM Prague Czechia
    12 Service de Chirurgie Cardiaque Grenoble France
    13 Hopital Cardiologique Lille France
    14 Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere Paris France
    15 Hôpital Pontchaillou Rennes France
    16 Charles Nicolle University Hospital Rouen France
    17 University of Freiburg Medical Center Freiburg Germany
    18 Medical University Hannover Hannover Germany

    Sponsors and Collaborators

    • Abbott Medical Devices
    • Thoratec Europe Ltd

    Investigators

    • Study Director: Pooja Chatterjee, Thoratec Europe Limited
    • Study Director: David Farrar, PhD, Thoratec Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01477528
    Other Study ID Numbers:
    • TC-081611
    First Posted:
    Nov 22, 2011
    Last Update Posted:
    Jun 24, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Abbott Medical Devices
    HeartMate II
    Anticoagulation
    Thoratec Corporation

    Study Results

    No Results Posted as of Jun 24, 2022