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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Thoratec Europe Ltd
ClinicalTrials.gov Identifier:
NCT01477528
First received: November 17, 2011
Last updated: September 23, 2014
Last verified: September 2014

November 17, 2011
September 23, 2014
November 2011
February 2015   (final data collection date for primary outcome measure)
Rate of thromboembolic events and hemorrhagic events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01477528 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

  • Anticoagulation
  • Left Ventricular Assist Device
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
April 2015
February 2015   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Czech Republic,   France,   Germany
 
NCT01477528
TC-081611
No
Thoratec Europe Ltd
Thoratec Europe Ltd
Thoratec Corporation
Study Director: Laura Damme, RN, MPH Thoratec Europe Limited
Study Director: Faouzi Kallel, PhD Thoratec Corporation
Thoratec Europe Ltd
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP