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Completed

NCT Number: NCT01477528

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Rate of thromboembolic events and hemorrhagic events

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Europe Ltd

Registry information

Official study title

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

Acronym: TRACE

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 22, 2011
Registry last updated
Jun 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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