A Study Addendum to the Medtronic, Inc. Product Surveillance Registry/Destination Therapy (DT) Post-Approval Study (PAS) Product Surveillance Registry

Overview

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
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CLS-20457164

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