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| Name | Class |
|---|---|
| Thoratec Europe Ltd | INDUSTRY |
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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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| Measure | Description | Time Frame |
|---|---|---|
| Rate of thromboembolic events and hemorrhagic events | 24 months |
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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:
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:
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Patients with HeartMate II VAD that are on reduced anticoagulation/antiplatelet regimine
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| Name | Affiliation | Role |
|---|---|---|
| Pooja Chatterjee | Thoratec Europe Limited | Study Director |
| David Farrar, PhD | Thoratec Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Memorial Hospital | San Diego | California | 92123 | United States | ||
| University of Florida (Shands) |
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| Gainesville |
| Florida |
| 32610 |
| United States |
| Advocate Christ Hospital | Oak Lawn | Illinois | 60453 | United States |
| Methodist Hospital of Indiana | Indianapolis | Indiana | 46202 | United States |
| St. Vincent Heart Center of Indiana | Indianapolis | Indiana | 46260 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| Medical University of Vienna | Vienna | Austria |
| IKEM | Prague | Czechia |
| 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 |
| University of Freiburg Medical Center | Freiburg im Breisgau | Germany |
| Medical University Hannover | Hanover | Germany |