Registry for patients undergoing cardiac surgery with Medtronic devices
SYMBIOSIS Post-Market Registry
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 |
|---|---|
| Enrollment | 5000 (estimated) |
| Sex | All |
| Sponsor | Medtronic Cardiac Surgery Industry-sponsored |
| Locations | 14 sites (Vienna and 13 other locations) |
| Trial ID | NCT04241328 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients undergoing procedures that utilize eligible Medtronic cardiac surgery products.
Not a fit: Patients currently participating in other interventional studies may not benefit from this registry due to potential confounding factors.
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 performed: Other observational registries have successfully identified device-related complications and improved patient safety, indicating a positive precedent for this approach.
Eligibility criteria
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 this trial is running
Vienna and 13 other locations
- AKH Wien — Vienna, Austria (Recruiting)
- Ziekenhuis Oost-Limburg — Genk, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- CHU d'Angers — Angers, France (Completed)
- Clinique Claude Bernard — Metz, France (Terminated)
- Uniklinik RWTH Aachen — Aachen, Germany (Recruiting)
- Herz- und Diabeteszentrum NRW — Bad Oeynhausen, Germany (Recruiting)
- Deutsches Herzzentrum München — Munich, Germany (Recruiting)
- Onassis Hospital — Athens, Greece (Active_not_recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Completed)
- Maastricht University Medical Center (MUMC+) — Maastricht, Netherlands (Active_not_recruiting)
- St. Antonius Ziekenhuis — Nieuwegein, Netherlands (Recruiting)
- Haukeland Universitetssjukehus — Bergen, Norway (Recruiting)
- Hospital Clinic Barcelona — Barcelona, Spain (Completed)
Study contacts
- Study coordinator: Lisa Lindelauf, BSc
- Email: lisa.lindelauf@medtronic.com
- Phone: +31611605434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.