Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMedtronic Cardiac Surgery
About this trial
The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subject or legally authorized representative provides written data release and/or informed consent per institution and/or geographical requirements prior to discharge from participating registry hospital.
Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Disqualifiers
Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Trial population
All consecutive subjects with the intent of being treated or treated (up to discharge from treating hospital) with a market-approved Medtronic CS product, are candidates to be enrolled. The Investigator will determine subject eligibility in SYMBIOSIS based upon the inclusion/exclusion criteria. If a subject meets all inclusion and none of the exclusion criteria, they will be informed about the SYMBIOSIS Registry. SYMBIOSIS will collect data of numerous patient conditions for which Medtronic CS products are being used.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Device Safety
Procedure- , device-related events and device deficiencies
Time frame
Procedural2
Device performance
Device Success
Time frame
ProceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov