A Study to Establish a Product Surveillance Registry (DTPAS) Apogee (addendum to the Medtronic, Inc. Product Surveillance Registry / Destination Therapy (DT) Post Approval Study (PAS)) Platform Addendum
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
- Jacksonville, Florida: 19-002050
Sponsor Protocol Number: 056-F275
About this study
The primary purpose of this study is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic 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 provides written 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 within specified enrollment window.
Exclusion Criteria:
- Patient who is, or is expected to be inaccessible for follow-up.
- Participation is excluded by local law.
- Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results.
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Kevin Landolfo, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available