NCT04073420
Recruiting
Not Applicable
Medtronic Cardiac Surgery Post Market Clinical Follow-up Registry
Medtronic Cardiac Surgery51 sites in 10 countries2,700 target enrollmentDecember 2, 2019
ConditionsValve Disease, Heart
Overview
- Phase
- Not Applicable
- Intervention
- Surgical Heart Valve Repair Products
- Conditions
- Valve Disease, Heart
- Sponsor
- Medtronic Cardiac Surgery
- Enrollment
- 2700
- Locations
- 51
- Primary Endpoint
- Identify unique failure modes
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
Brief Summary
This registry is being conducted to support ongoing post-market surveillance activities.
Investigators
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 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 Criteria
- •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
Arms & Interventions
Surgical Valve Replacement and/or Repair Patients
Intervention: Surgical Heart Valve Repair Products
Surgical Valve Replacement and/or Repair Patients
Intervention: Surgical Heart Valve Replacement Products
Outcomes
Primary Outcomes
Identify unique failure modes
Time Frame: 10 years
Identify trends in adverse device effects
Time Frame: 10 years
Study Sites (51)
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