Product Surveillance Registry-APV

Overview

About this study

The 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, to obtain real-world performance and safety information from a global network of hospitals, clinics, and clinicians intended to represent the range of clinical environments in which Medtronic products are used to support post-market surveillance activities and post-approval studies that are initiated by Medtronic, regulated by local governments, or are conducted to fulfill government and/ or regulatory authority requests, to obtain clinical evidence to guide the development and improvement of medical devices, therapies, device guidelines, and patient services/solutions and to provide clinical data to support health economics and clinical outcomes research.

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 all-around product safety and/or effectiveness).

 

 

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

Rochester, Minn.

Mayo Clinic principal investigator

Sanjay Misra, M.D.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Jennifer Murphy

(507) 538-0540

Murphy.Jennifer@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20523998

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