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. If you need assistance understanding the eligibility criteria, please contact the study team.

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 product.
  • Patient is consented within the enrollment window of the treatment/therapy received, refer to the applicable Condition/Therapy Appendix.

Exclusion Criteria:

  • Patient who is, or is expected to be inaccessible for follow-up.
  • Patient with exclusion criteria required by local law.
  • Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

John Stulak, M.D.

Open for enrollment

Contact information:

Jennifer Martin

(507)422-0887

Martin.Jennifer2@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20457164

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