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Recruiting NCT04241328

Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Observational Cardiovascular Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, France, Germany, Greece +3
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

SYMBIOSIS Post-Market Registry

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.

Detailed 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

Primary outcome measures

  • Device Safety [Time frame: Procedural]
  • Device performance [Time frame: Procedural]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Germany · 3 centers
  • Uniklinik RWTH Aachen — Aachen
  • Herz- und Diabeteszentrum NRW — Bad Oeynhausen
  • Deutsches Herzzentrum München — Munich
Netherlands · 3 centers
  • Catharina Ziekenhuis — Eindhoven
  • Maastricht University Medical Center (MUMC+) — Maastricht
  • St. Antonius Ziekenhuis — Nieuwegein
Belgium · 2 centers
  • Ziekenhuis Oost-Limburg — Genk
  • UZ Leuven — Leuven
France · 2 centers
  • CHU d'Angers — Angers
  • Clinique Claude Bernard — Metz
Austria · 1 center
  • AKH Wien — Vienna
Greece · 1 center
  • Onassis Hospital — Athens
Norway · 1 center
  • Haukeland Universitetssjukehus — Bergen
Spain · 1 center
  • Hospital Clinic Barcelona — Barcelona

Identifiers

NCT: NCT04241328 · MDT19022PMF001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗