A Study Addendum to the Medtronic, Inc. Product Surveillance Registry/Destination Therapy (DT) Post-Approval Study (PAS) Product Surveillance Registry
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: 18-010774
Sponsor Protocol Number: 056-F275
About this study
The purpose of this product surveillance registry (PSR) study is to provide continuing evaluation and and periodic reporting of safety and effectiveness of market-released products for their intended use.
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:
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
- Patient has, or is intended to receive or be treated with, an eligible Medtronic product.
- Patient is consented within the enrollment window of the therapy received, as applicable.
Exclusion Criteria:
- Patient who is, or is expected to be, inaccessible for follow-up.
- Patient is excluded by local law.
- Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the PSR results (i.e., no required intervention that could affect interpretation of allaround product safety and/or effectiveness).
Eligibility last updated 11/1/21. Questions regarding updates should be directed to the study team contact.
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