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

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 Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Kevin Landolfo, M.D.

Open for enrollment

Contact information:

Mauricia Buchanan R.N.

127or7839455

Buchanan.Mauricia@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-20463656

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