Clinical trial NCT04241328: Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
Official title: SYMBIOSIS Post-Market Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Medtronic Cardiac Surgery
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief 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.

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

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

Primary outcomes:
measure: Device Safety
timeFrame: Procedural
measure: Device performance
timeFrame: Procedural
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH Wien
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Leuven
country: Belgium
facility: UZ Leuven
city: Angers
country: France
facility: CHU d'Angers
city: Metz
country: France
facility: Clinique Claude Bernard
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: Athens
country: Greece
facility: Onassis Cardiac Surgery Center
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center (MUMC+)
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
city: Bergen
country: Norway
facility: Haukeland Universitetssjukehus
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
Study officials:
References: