Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
NCT ID: NCT04241328
Last Updated: 2025-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
5000 participants
OBSERVATIONAL
2020-01-09
2026-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Subject will undergo or underwent a procedure in which an eligible Medtronic CS product is/was used.
Exclusion Criteria
ALL
No
Sponsors
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Medtronic Cardiac Surgery
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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D Wiedemann, Prof. Dr.
Role: primary
Christiaan van Kerrebroeck, Dr.
Role: primary
Wouter Oosterlinck, Doctor
Role: primary
Prof. Dr. Dodge Khatami
Role: primary
Jan Gummert, Professor
Role: primary
Keti Vitanova, Dr. med.
Role: primary
Dr. Bart van Putte
Role: primary
Rune Haaverstad, Professor
Role: primary
Other Identifiers
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MDT19022PMF001
Identifier Type: -
Identifier Source: org_study_id
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