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Completed

NCT Number: NCT02158403

PREVENtion of HeartMate II Pump Thrombosis

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.

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Key information

Conditions

HeartMate II Pump Thrombosis Cardiovascular Diseases Embolism and Thrombosis Thrombosis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baptist Medical Center, Little Rock, Arkansas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Management Recommendations for reducing pump thrombosis

Other

Clinical Management Recommendations for reducing pump thrombosis

Primary outcomes

  1. Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation

    Time frame: 3 months

Secondary outcomes

  1. Incidence of confirmed pump thrombosis within six months of HM II implantation

    Time frame: 6 months

  2. Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation

    Time frame: 3 and 6 months

  3. 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

  4. Survival on LVAD support at six months post HM II implantation

    Time frame: 6 months

  5. 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

  6. Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation

    Time frame: Baseline and 3 months after implant

  7. 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

  8. 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

  9. Incidence of protocol-defined anticipated adverse events

    Time frame: Baseline, 1 month , 3 months and 6 months after surgery

  10. 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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Thoratec Corporation

Registry information

Official study title

PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management

Acronym: PREVENT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2014
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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