Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT04241328
• Lead Sponsor: Medtronic Cardiac Surgery

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

Study Timeline

• Study Start: 2020-01-09
• Study First Submitted: 2020-01-22
• Study First Submitted QC: 2020-01-22
• Study First Posted: 2020-01-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-27
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Device Safety	Procedural	Procedure- , device-related events and device deficiencies
Device performance	Procedural	Device Success

Trial Locations

Locations (14)

UZ Leuven; 🇧🇪 Leuven, Belgium

AKH Wien; 🇦🇹 Wien, Austria

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

CHU d'Angers; 🇫🇷 Angers, France

Uniklinik RWTH Aachen; 🇩🇪 Aachen, Germany

Herz- und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Clinique Claude Bernard; 🇫🇷 Metz, France

Deutsches Herzzentrum München; 🇩🇪 Munich, Germany

Onassis Cardiac Surgery Center; 🇬🇷 Athens, Greece

Maastricht University Medical Center (MUMC+); 🇳🇱 Maastricht, Netherlands

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Haukeland Universitetssjukehus; 🇳🇴 Bergen, Norway

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain