Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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 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 Design
Outcome Measures
Primary Outcome Measures
- Device Safety [Procedural]
Procedure- , device-related events and device deficiencies
- Device performance [Procedural]
Device Success
Eligibility Criteria
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | AKH Wien | Wien | Austria | 1090 | |
2 | Ziekenhuis Oost-Limburg | Genk | Belgium | 3600 | |
3 | UZ Leuven | Leuven | Belgium | ||
4 | CHU d'Angers | Angers | France | ||
5 | Herz- und Diabeteszentrum NRW | Bad Oeynhausen | Germany | ||
6 | Onassis Cardiac Surgery Center | Athens | Greece | ||
7 | Catharina Ziekenhuis | Eindhoven | Netherlands | 5623 EJ | |
8 | Maastricht University Medical Center (MUMC+) | Maastricht | Netherlands | 6229 HX | |
9 | St. Antonius Ziekenhuis | Nieuwegein | Netherlands | ||
10 | Haukeland Universitetssjukehus | Bergen | Norway | ||
11 | Hospital Clinic Barcelona | Barcelona | Spain | 08036 |
Sponsors and Collaborators
- Medtronic Cardiac Surgery
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT19022PMF001