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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
300
Clinical Management Recommendations for reducing pump thrombosis
Baptist Medical Center
Little Rock, Arkansas, United States
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
Time frame: 3 months
Incidence of confirmed pump thrombosis within six months of HM II implantation
Time frame: 6 months
Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation
Time frame: 3 and 6 months
Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation
Time frame: 3 and 6 months
Survival on LVAD support at six months post HM II implantation
Time frame: 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
Time frame: Baseline and 1 week, 1 month, 3 months and 6 months after surgery
Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation
Time frame: Baseline and 3 months after implant
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)
Time frame: 1 week and 6 months after surgery
Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population
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University of California, San Diego
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Sutter Memorial
Sacramento, California, United States
Sharp Memorial Hospital
San Diego, California, United States
University of Colorado
Aurora, Colorado, United States
Shands Hospital at University of Florida
Gainesville, Florida, United States
Northwestern Memorial
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Jewish Hospital
Louisville, Kentucky, United States
...and 13 more locations
Time frame: 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
Incidence of protocol-defined anticipated adverse events
Time frame: Baseline, 1 month , 3 months and 6 months after surgery
Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index
Time frame: 1 week, 1 month, 3 months, and 6 months after surgery