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

June 23, 2022 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

201

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria
        • Medical University of Vienna
  • Czechia
      • Prague, Czechia
        • IKEM
  • France
      • Grenoble, France
        • Service de Chirurgie Cardiaque
      • Lille, France
        • Hôpital Cardiologique
      • Paris, France
        • Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere
      • Rennes, France
        • Hôpital Pontchaillou
      • Rouen, France
        • Charles Nicolle University Hospital
  • Germany
      • Freiburg, Germany
        • University of Freiburg Medical Center
      • Hannover, Germany
        • Medical University Hannover
  • United States
    • California
      • San Diego, California, United States, 92123
        • Sharp Memorial Hospital
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida (Shands)
    • Illinois
      • Oak Lawn, Illinois, United States, 60453
        • Advocate Christ Hospital
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital of Indiana
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Heart Center of Indiana
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with HeartMate II VAD that are on reduced anticoagulation/antiplatelet regimine

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of thromboembolic events and hemorrhagic events
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Thoratec Europe Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 17, 2011

First Submitted That Met QC Criteria

November 21, 2011

First Posted (Estimate)

November 22, 2011

Study Record Updates

Last Update Posted (Actual)

June 24, 2022

Last Update Submitted That Met QC Criteria

June 23, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • TC-081611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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