Status:
RECRUITING
Medtronic Cardiac Surgery PMCF Registry
Lead Sponsor:
Medtronic Cardiac Surgery
Conditions:
Valve Disease, Heart
Eligibility:
All Genders
Brief Summary
This registry is being conducted to support ongoing post-market surveillance activities.
Eligibility Criteria
Inclusion
- 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 within enrollment window of treatment/therapy received at the time of their initial Registry enrollment, or meets criteria for retrospective enrollment
Exclusion
- Patient who is, or is expected to be, inaccessible for follow-up
- Patient prohibited from participation by local law
- Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or device study that may confound results
Key Trial Info
Start Date :
December 2 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2039
Estimated Enrollment :
2700 Patients enrolled
Trial Details
Trial ID
NCT04073420
Start Date
December 2 2019
End Date
December 31 2039
Last Update
October 15 2025
Active Locations (26)
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1
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Mount Sinai Medical Center
New York, New York, United States, 10029
4
Saint Francis Hospital
Roslyn, New York, United States, 11576