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:
Thoratec Europe Ltd
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
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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