CompletedNot Applicable

PREVENtion of HeartMate II Pump Thrombosis

United States300 participantsStarted 2014-09

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: 3 months

Trial details

NCT IDNCT02158403

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More HeartMate II Pump Thrombosis trials