Registry for patients undergoing cardiac surgery with Medtronic devices
Official title: SYMBIOSIS Post-Market Registry
Run by Medtronic Cardiac Surgery · NCT04241328 · Data updated 2026-11-12
This study is collecting information from patients who have had heart surgery using Medtronic devices to see how safe and effective these products are in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 5000 (estimated) |
| Sponsor | Medtronic Cardiac Surgery Industry-sponsored |
| Locations | 14 sites (Vienna and 13 other locations) |
| Status | Recruiting |
| Started | January 9, 2020 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT04241328 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients undergoing procedures that utilize eligible Medtronic cardiac surgery products.
✕Probably not a fit
Patients currently participating in other interventional studies may not benefit from this registry due to potential confounding factors.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational, multi-center registry aims to collect real-world data on the safety and performance of Medtronic cardiac surgery products. It focuses on identifying any new device-related complications and evaluating device success by monitoring adverse events and general performance. Patients enrolled in the registry will be followed according to routine care practices at their treating hospitals, ensuring comprehensive data collection on demographics and safety events.
Why it matters
Potential benefit: If successful, this registry could enhance the safety and effectiveness of cardiac surgery devices, leading to improved patient outcomes.
How similar studies have gone: Other observational registries have successfully identified device-related complications and improved patient safety, indicating a positive precedent for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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AKH Wien
Vienna, Austria Recruiting -
Uniklinik RWTH Aachen
Aachen, Germany Recruiting -
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, Germany Recruiting -
Deutsches Herzzentrum München
Munich, Germany Recruiting -
St. Antonius Ziekenhuis
Nieuwegein, Netherlands Recruiting -
Ziekenhuis Oost-Limburg
Genk, Belgium Completed
Show 8 more locations
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UZ Leuven
Leuven, Belgium Completed -
CHU d'Angers
Angers, France Completed -
Clinique Claude Bernard
Metz, France Terminated -
Onassis Hospital
Athens, Greece Active not recruiting -
Catharina Ziekenhuis
Eindhoven, Netherlands Completed -
Maastricht University Medical Center (MUMC+)
Maastricht, Netherlands Active not recruiting -
Haukeland Universitetssjukehus
Bergen, Norway Suspended -
Hospital Clinic Barcelona
Barcelona, Spain Completed
Study contacts
- Study coordinator: Lisa Lindelauf, BSc
- Email: lisa.lindelauf@medtronic.com
- Phone: +31611605434
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.