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Recruiting NCT04241328

Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Conditions: Cardiovascular Diseases

Sponsor: Medtronic Cardiac Surgery

trial.available_in: БГ
Overview
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.
Description
The objective is to collect product safety and performance data for Medtronic CE (Conformitè Europëenne )-Marked Cardiac Surgery, including perfusion (CS) products. The main goals of this data collection are as follows: * Identification of any (new) device-related complications including events which were not anticipated or documented in the Instructions For Use (IFU), or Risk Management Plan, or Clinical Evidence Evaluation report, or Design Failure Modes and Effect Analysis * Evaluation of device success defined as the absence of any probable or causal device-related adverse events or device deficiencies * Evaluation of general device performance when applicable Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital. Inclusion Criteria: * 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 Criteria: • Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry Data collection includes, for example: * Demographics * Product performance information * Safety Events
Who can participate
Inclusion Criteria: * 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 Criteria: * Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry
Locations 14
Austria (1)
AKH Wien
Vienna
Belgium (2)
Ziekenhuis Oost-Limburg
Genk
UZ Leuven
Leuven
France (2)
CHU d'Angers
Angers
COMPLETED
Clinique Claude Bernard
Metz
TERMINATED
Germany (3)
Uniklinik RWTH Aachen
Aachen
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Deutsches Herzzentrum München
Munich
Greece (1)
Onassis Hospital
Athens
ACTIVE_NOT_RECRUITING
Netherlands (3)
Catharina Ziekenhuis
Eindhoven
COMPLETED
Maastricht University Medical Center (MUMC+)
Maastricht
ACTIVE_NOT_RECRUITING
St. Antonius Ziekenhuis
Nieuwegein
Norway (1)
Haukeland Universitetssjukehus
Bergen
Spain (1)
Hospital Clinic Barcelona
Barcelona
COMPLETED
Technical details
Status
Recruiting
Study type
OBSERVATIONAL
Sex
Male and female
Healthy volunteers
No
Start date
09.01.2020
Completion date
31.12.2026
Registry ID
NCT04241328
Source
clinicaltrials.gov
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