A Study Registry of the TandemHeart Blood Pump System to Collect Data to Help Understand Clinical Results
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: 15-008055
NCT ID: NCT02326402
Sponsor Protocol Number: 9900-0005
About this study
This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, it will provide insight into disease defining characteristics that resulted in the clinical decision to use TandemHeart for mechanical support, and also enhance knowledge of best practices regarding clinical management, weaning from the device and removal/exit strategies.
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
- Has had the TandemHeart System inserted percutaneously (e.g. in the cath lab or peri-operatively)
- Age > 18
- Patient (or legally authorized representative) has signed informed consent
Exclusion Criteria
- Is incarcerated (a prisoner)
- Is participating in a clinical trial of another investigational device or drug
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 David Joyce, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available