PREVENtion of HeartMate II Pump Thrombosis
- Conditions
- HeartMate II Pump Thrombosis
- Interventions
- Other: Clinical Management Recommendations for reducing pump thrombosis
- Registration Number
- NCT02158403
- Lead Sponsor
- Abbott Medical Devices
- Brief Summary
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.
- Detailed Description
PREVENT is a prospective, multi-center, non-randomized study that is designed (1) to assess the incidence of HM II pump thrombosis in the current era when recommended practices for clinical management are adopted, and (2) to identify the risk factors associated with pump thrombosis events. The recommended practices are focused on implantation technique, anticoagulation regimen, pump speed and blood pressure management. All consecutive patients receiving a HM II implant will be considered for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Clinical Management Recommendations Clinical Management Recommendations for reducing pump thrombosis Clinical management recommendations for reducing pump thrombosis
- Primary Outcome Measures
Name Time Method Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation 3 months
- Secondary Outcome Measures
Name Time Method Survival on LVAD support at six months post HM II implantation 6 months 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 Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation 3 and 6 months Incidence of protocol-defined anticipated adverse events Baseline, 1 month , 3 months and 6 months after surgery 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 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 Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation Baseline and 3 months after implant 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 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 Incidence of confirmed pump thrombosis within six months of HM II implantation 6 months
Trial Locations
- Locations (23)
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Sutter Memorial
🇺🇸Sacramento, California, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Northwestern Memorial
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Jewish Hospital
🇺🇸Louisville, Kentucky, United States
Abbott Northwestern
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic, St. Mary's
🇺🇸Rochester, Minnesota, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, 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
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Memorial Hermann/UT Texas
🇺🇸Houston, Texas, United States
Baptist Medical Center
🇺🇸Little Rock, Arkansas, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
Sharp Memorial Hospital
🇺🇸San Diego, California, United States
Shands Hospital at University of Florida
🇺🇸Gainesville, Florida, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States