HeartMate II Pump Thrombosis Clinical Trial
— PREVENTOfficial title:
PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management
| NCT number | NCT02158403 |
| Other study ID # | TC05232014 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2014 |
| Est. completion date | June 2016 |
| Verified date | March 2022 |
| Source | Abbott Medical Devices |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.
| Status | Completed |
| Enrollment | 300 |
| Est. completion date | June 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Subject or legally authorized representative has signed an informed consent form - Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD) Exclusion Criteria: - Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump) - Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome |
| Country | Name | City | State |
|---|---|---|---|
| United States | Abington Memorial Hospital | Abington | Pennsylvania |
| United States | University of Colorado | Aurora | Colorado |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | Northwestern Memorial | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | The Christ Hospital | Cincinnati | Ohio |
| United States | Ohio State University | Columbus | Ohio |
| United States | Inova Fairfax Hospital | Falls Church | Virginia |
| United States | Shands Hospital at University of Florida | Gainesville | Florida |
| United States | Memorial Hermann/UT Texas | Houston | Texas |
| United States | University of California, San Diego | La Jolla | California |
| United States | Baptist Medical Center | Little Rock | Arkansas |
| United States | UCLA Medical Center | Los Angeles | California |
| United States | Jewish Hospital | Louisville | Kentucky |
| United States | Abbott Northwestern | Minneapolis | Minnesota |
| United States | University of Minnesota Medical Center | Minneapolis | Minnesota |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | Allegheny General Hospital | Pittsburgh | Pennsylvania |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Mayo Clinic, St. Mary's | Rochester | Minnesota |
| United States | Sutter Memorial | Sacramento | California |
| United States | Sharp Memorial Hospital | San Diego | California |
| Lead Sponsor | Collaborator |
|---|---|
| Abbott Medical Devices | Thoratec Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation | 3 months | ||
| Secondary | Incidence of confirmed pump thrombosis within six months of HM II implantation | 6 months | ||
| Secondary | Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation | 3 and 6 months | ||
| Secondary | Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation | 3 and 6 months | ||
| Secondary | Survival on LVAD support at six months post HM II implantation | 6 months | ||
| Secondary | Multivariate analysis of risk factors for pump thrombosis including demographics, anti-coagulation regimen, selected laboratory data (INR, LDH, plasma free Hgb), pump position measures, pump parameters and blood pressure | Baseline and 1 week, 1 month, 3 months and 6 months after surgery | ||
| Secondary | Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation | Baseline and 3 months after implant | ||
| Secondary | Characterization of pump position in the study population (measured via quantitative assessment of X-ray images including inflow cannula angle, outflow cannula angle and pump pocket depth) | 1 week and 6 months after surgery | ||
| Secondary | Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population | Baseline, 1 week (plus or minus 3 days), 1 month (plus or minus 7 days), 3 months and 6 months (plus or minus 30 days) after surgery | ||
| Secondary | Incidence of protocol-defined anticipated adverse events | Baseline, 1 month , 3 months and 6 months after surgery | ||
| Secondary | Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index | 1 week, 1 month, 3 months, and 6 months after surgery |