A Study of the Incidence and Risk Factors Associated with HeartMate II Pump Thrombosis Events

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential 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 in an investigation(s) that is likely to confound study results or affect study outcome

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

John Stulak, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20273176

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