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

This study is currently recruiting participants.
Verified May 2013 by Thoratec Europe Ltd
Sponsor:
Collaborator:
Thoratec Corporation
Information provided by (Responsible Party):
Thoratec Europe Ltd
ClinicalTrials.gov Identifier:
NCT01477528
First received: November 17, 2011
Last updated: May 14, 2013
Last verified: May 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477528

Locations
United States, California
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Marcia Stahovich         marcia.stahovich@sharp.com    
Principal Investigator: Robert Adamson, MD            
United States, Florida
University of Florida (Shands) Recruiting
Gainesville, Florida, United States, 32610
Contact: Debra Robertson         debra.robertson@surgery.ufl.edu    
Principal Investigator: Charles Klodell, MD            
United States, Illinois
Advocate Christ Hospital Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Mary Jane Borg         mborg@ctvsurgeons.com    
Principal Investigator: Antone Tatooles, MD            
United States, Indiana
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Regina Margiotti         rmargiotti@thecaregroup.com    
Principal Investigator: Mary Walsh, MD            
Methodist Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Ronda McNamee         mcnamee@iuhealth.org    
Principal Investigator: Thomas Wozniak, MD            
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Carol Toninato         ctoninato@umphysicians.umn.edu    
Principal Investigator: Ranjit John            
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Kathy Idrissi         kc286@columbia.edu    
Principal Investigator: Ulrich Jorde, MD            
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Milton Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Andrea Myers         amyers1@hmc.psu.edu    
Principal Investigator: Aly El Banayosy, MD            
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Ruth Cavales         rcavales@wpahs.org    
Principal Investigator: Raymond Benza, MD            
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Daniel Zimpfer, MD, PhD         daniel.zimpfer@meduniwien.ac.at    
Principal Investigator: Daniel Zimpfer, MD, PhD            
Belgium
Cliniques Universitaires St. Luc Not yet recruiting
Brussels, Belgium
Contact: Luc-Marie Jacquet, MD, PhD         Luc-Marie.Jacquet@uclouvain.be    
Principal Investigator: Luc-Marie Jacquet, MD, PhD            
Czech Republic
IKEM Recruiting
Prague, Czech Republic
Contact: Netuka, MD         ivan.netuka@ikem.cz    
Principal Investigator: Ivan Netuka, MD, PhD            
France
Service de Chirurgie Cardiaque Not yet recruiting
Grenoble, France
Contact: Olivier Chavanon, MD, PhD         ochavanon@chu-grenoble.fr    
Principal Investigator: Olivier Chavanon, MD, PhD            
Hopital Cardiologique Recruiting
Lille, France
Contact: Vincentelli         an.vincentelli@gmail.com    
Principal Investigator: Andre Vincentelli, MD, PhD            
Chirurgie Thoracique et Cardiovasculaire Groupe hospitalier Pitie-Salpetriere Recruiting
Paris, France
Contact: Pascal Leprince, MD, PhD         pascal.leprince@psl.aphp.fr    
Principal Investigator: Pascal Leprince, MD, PhD            
Hôpital Pontchaillou Recruiting
Rennes, France
Contact: Erwan Flecher, MD         erwan.flecher@chu-rennes.fr    
Principal Investigator: Erwan Flecher, MD            
Germany
Herz und Diabeteszentrum NRW Not yet recruiting
Bad Oeynhausen, Germany
Contact: Micheil Morshuis, MD         mmorshuis@hdz-nrw.de    
Principal Investigator: Michiel Morshuis, MD            
University of Freiburg Medical Center Recruiting
Freiburg, Germany
Contact: Gabriele Lechner         gariele.lechner@uniklinik-freiburg.de    
Principal Investigator: Beyersdorf, MD, PhD            
Universitatsklinikum Halle Not yet recruiting
Halle, Germany
Contact: Detrich Metz, MD         dietrich.metz@medizin.uni-halle.de    
Principal Investigator: Detrich Metz, MD            
Medical University Hannover Not yet recruiting
Hannover, Germany
Contact: Jan Schmitto, MD         Schmitto.Jan@mh-hannover.de    
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: May 14, 2013
Health Authority: Czech Republic: Ethics Committee
Germany: Ethics Commission
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Sweden: Institutional Review Board
United States: Institutional Review Board
Belgium: Ethics Committee

Keywords provided by Thoratec Europe Ltd:
HeartMate II
Anticoagulation

ClinicalTrials.gov processed this record on May 21, 2013