Overview

This trial has been completed.

Condition heartmate ii pump thrombosis
Treatment clinical management recommendations for reducing pump thrombosis
Sponsor Thoratec Corporation
Start date September 2014
End date March 2016
Trial size 300 participants
Trial identifier NCT02158403, TC05232014

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Other)
Clinical management recommendations for reducing pump thrombosis
clinical management recommendations for reducing pump thrombosis
Clinical Management Recommendations for reducing pump thrombosis

Primary Outcomes

Measure
Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation
time frame: 3 months

Secondary Outcomes

Measure
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
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

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by St. Jude Medical.