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Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

SYMBIOSIS Post-Market Registry

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04241328
Acronym
SYMBIOSIS
Enrollment
5000
Registered
2020-01-27
Start date
2020-01-09
Completion date
2026-12-31
Last updated
2026-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases

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.

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 probable or causal 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

Interventions

None listed

Sponsors

Medtronic Cardiac Surgery
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Device SafetyProceduralProcedure- , device-related events and device deficiencies
Device performanceProceduralDevice Success

Countries

Austria, Belgium, France, Germany, Greece, Netherlands, Norway, Spain

Contacts

CONTACTLisa Lindelauf, BSc
lisa.lindelauf@medtronic.com+31611605434

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 31, 2026