PREVENtion of HeartMate II Pump Thrombosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management

Conditions
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HeartMate II Pump Thrombosis

Intervention / Treatment
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* Other: Clinical Management Recommendations for reducing pump thrombosis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clinical Management Recommendations<br>Clinical management recommendations for reducing pump thrombosis | Other: Clinical Management Recommendations for reducing pump thrombosis<br>* Clinical Management Recommendations for reducing pump thrombosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of confirmed pump thrombosis within six months of HM II implantation |  | 6 months | 
| Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation |  | 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 |  | 3 and 6 months | 
| 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 | 
| Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation |  | 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) |  | 1 week and 6 months after surgery | 
| 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 | 
| Incidence of protocol-defined anticipated adverse events |  | 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 |  | 1 week, 1 month, 3 months, and 6 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HeartMate II, heart assist device, pump thrombosis, hypercoagulable disorder, thrombus, Thoratec Corporation