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: July 31, 2014
Last verified: July 2014
  Purpose

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
Anticoagulation
Left Ventricular Assist Device

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II LVAS (TRACE)

Further study details as provided by Thoratec Europe Ltd:

Primary Outcome Measures:
  • Rate of thromboembolic events and hemorrhagic events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477528

Locations
United States, California
Sharp Memorial Hospital
San Diego, California, United States, 92123
United States, Florida
University of Florida (Shands)
Gainesville, Florida, United States, 32610
United States, Illinois
Advocate Christ Hospital
Oak Lawn, Illinois, United States, 60453
United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46260
Methodist Hospital of Indiana
Indianapolis, Indiana, United States, 46202
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Austria
Medical University of Vienna
Vienna, Austria
Czech Republic
IKEM
Prague, Czech Republic
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, France
Germany
University of Freiburg Medical Center
Freiburg, Germany
Medical University Hannover
Hannover, Germany
Sponsors and Collaborators
Thoratec Europe Ltd
Thoratec Corporation
Investigators
Study Director: Laura Damme, RN, MPH Thoratec Europe Limited
Study Director: Faouzi Kallel, PhD Thoratec Corporation
  More Information

No publications provided

Responsible Party: Thoratec Europe Ltd
ClinicalTrials.gov Identifier: NCT01477528     History of Changes
Other Study ID Numbers: TC-081611
Study First Received: November 17, 2011
Last Updated: July 31, 2014
Health Authority: Czech Republic: Ethics Committee
Germany: Ethics Commission
France: Afssaps - French Health Products Safety Agenc
United States: Institutional Review Board

Keywords provided by Thoratec Europe Ltd:
HeartMate II
Anticoagulation

ClinicalTrials.gov processed this record on August 28, 2014