RecruitingNCT01524276
Product Surveillance Registry
Medtronic Product Surveillance Registry
Sponsor
Medtronic
Enrollment
100,000 participants
Start Date
Jan 1, 2012
Study Type
OBSERVATIONAL
Conditions
Summary
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products. The Registry data is intended to benefit and support interests of patients, hospitals, clinicians, regulatory bodies, payers, and industry by streamlining the clinical surveillance process and facilitating leading edge performance assessment via the least burdensome approach.
Eligibility
Inclusion Criteria3
- 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 Criteria2
- Patient who is, or will be, inaccessible for follow-up
- Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
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Locations(389)
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NCT01524276
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