Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

NCT04241328 | Recruiting

• 1 other identifier: MDT19022PMF001
• Study Type: observational
• Target: 5,000
• Locations: 8 countries
• Sites: 14

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

• Device Safety

  Procedure- , device-related events and device deficiencies

  Procedural

• Device performance

  Device Success

  Procedural

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Currently participating in an interventional drug or device study which may induce confounding factor(s) to the results from this Registry

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead

Study Sites (14)

AKH Wien

Vienna, 1090, Austria

RECRUITING

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

RECRUITING

UZ Leuven

Leuven, Belgium

RECRUITING

CHU d'Angers

Angers, France

COMPLETED

Clinique Claude Bernard

Metz, 57070, France

TERMINATED

Uniklinik RWTH Aachen

Aachen, Germany

RECRUITING

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, Germany

RECRUITING

Deutsches Herzzentrum München

Munich, 80636, Germany

RECRUITING

Onassis Hospital

Athens, Greece

ACTIVE NOT RECRUITING

Catharina Ziekenhuis

Eindhoven, 5623 EJ, Netherlands

COMPLETED

Maastricht University Medical Center (MUMC+)

Maastricht, 6229 HX, Netherlands

ACTIVE NOT RECRUITING

St. Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Haukeland Universitetssjukehus

Bergen, Norway

RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

COMPLETED

MeSH Terms

Conditions

Cardiovascular Diseases

Central Study Contacts

Lisa Lindelauf, BSc

CONTACT

+31611605434; lisa.lindelauf@medtronic.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2020
• First Posted: January 27, 2020
• Study Start: January 9, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); BE (2); GR (1); NL (3); ES (1); NO (1); DE (3); FR (2)