A Study of the Incidence and Risk Factors Associated with HeartMate II Pump Thrombosis Events
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-004710
NCT ID: NCT02158403
Sponsor Protocol Number: TC05232014
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