Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Subjects are enrolled and, if applicable, followed according to routine care practices at their treating hospital.
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Device Safety | Procedure- , device-related events and device deficiencies | Procedural |
| Device performance | Device Success | Procedural |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Lindelauf, BSc | Contact | +31611605434 | lisa.lindelauf@medtronic.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Wien | Recruiting | Vienna | 1090 | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ziekenhuis Oost-Limburg | Recruiting | Genk | 3600 | Belgium |
|
| UZ Leuven | Recruiting | Leuven | Belgium |
|
| CHU d'Angers | Completed | Angers | France |
| Clinique Claude Bernard | Terminated | Metz | 57070 | France |
| Uniklinik RWTH Aachen | Recruiting | Aachen | Germany |
|
| Herz- und Diabeteszentrum NRW | Recruiting | Bad Oeynhausen | Germany |
|
| Deutsches Herzzentrum München | Recruiting | Munich | 80636 | Germany |
|
| Onassis Hospital | Active, not recruiting | Athens | Greece |
| Catharina Ziekenhuis | Completed | Eindhoven | 5623 EJ | Netherlands |
| Maastricht University Medical Center (MUMC+) | Active, not recruiting | Maastricht | 6229 HX | Netherlands |
| St. Antonius Ziekenhuis | Recruiting | Nieuwegein | Netherlands |
|
| Haukeland Universitetssjukehus | Suspended | Bergen | Norway |
| Hospital Clinic Barcelona | Completed | Barcelona | 08036 | Spain |