RecruitingNCT04241328

Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

SYMBIOSIS Post-Market Registry


Sponsor

Medtronic Cardiac Surgery

Enrollment

5,000 participants

Start Date

Jan 9, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

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

Inclusion Criteria2

  • 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.

Exclusion Criteria1

  • Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry

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Locations(14)

AKH Wien

Vienna, Austria

Ziekenhuis Oost-Limburg

Genk, Belgium

UZ Leuven

Leuven, Belgium

CHU d'Angers

Angers, France

Clinique Claude Bernard

Metz, France

Uniklinik RWTH Aachen

Aachen, Germany

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

Deutsches Herzzentrum München

Munich, Germany

Onassis Hospital

Athens, Greece

Catharina Ziekenhuis

Eindhoven, Netherlands

Maastricht University Medical Center (MUMC+)

Maastricht, Netherlands

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

Haukeland Universitetssjukehus

Bergen, Norway

Hospital Clinic Barcelona

Barcelona, Spain

View Full Details on ClinicalTrials.gov

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NCT04241328


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