Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Cardiovascular Diseases Clinical Trial

— SYMBIOSIS  

Official title:

SYMBIOSIS Post-Market Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04241328
• Other study ID #: MDT19022PMF001
• Status: Recruiting
• Start date: January 9, 2020
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Medtronic Cardiac Surgery
• Contact: Lisa Lindelauf, BSc
• Phone: +31611605434
• Email: lisa.lindelauf[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Surgery

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Greece,  Netherlands,  Norway,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Safety	Procedure- , device-related events and device deficiencies	Procedural
Primary	Device performance	Device Success	Procedural