Medtronic Cardiac Surgery PMCF Registry
ConditionValve Disease, Heart
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedtronic Cardiac Surgery
About this trial
This registry is being conducted to support ongoing post-market surveillance activities.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Subjects requiring heart valve therapy replacement and/or repair.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Surgical Heart Valve Repair Products
DeviceSurgical heart valve repair products.
Surgical Heart Valve Replacement Products
DeviceSurgical heart valve replacement products.
Treatment groups
2,700 Participants
are divided into 1 treatment groupGroup A: Surgical Valve Replacement and/or Repair Patients2 interventions
Trial outcomes
Primary outcomes
1
Identify unique failure modes
Time frame
10 years2
Identify trends in adverse device effects
Time frame
10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov