Product Surveillance Registry (PSR)

Trial Purpose and Description

Provide continuing evaluation and periodic reporting of safety and effectiveness of market-released Medtronic products for their intended use.

Gender: Both


Eligibility Criteria

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 enrollment window relative to therapy initiation or meets criteria for retrospective enrollment

Exclusion Criteria:

  • Patient who is, or will 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

Medtronic, Inc

Dates: 05/09/2013 - 03/01/2018

Last Updated: 12/04/2016

Study HIC#: 1303011669REG

Get Involved

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email helpusdiscover@yale.edu or call 1-877-978-8348.

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Investigators

Rachel J. Lampert

Principal Investigator

Sub-Investigators