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Clinical Trials/NCT04241328
NCT04241328
Recruiting
Not Applicable

SYMBIOSIS Post-Market Registry

Medtronic Cardiac Surgery26 sites in 8 countries5,000 target enrollmentJanuary 9, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Medtronic Cardiac Surgery
Enrollment
5000
Locations
26
Primary Endpoint
Device Safety
Status
Recruiting
Last Updated
10 days ago

Overview

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

Registry
clinicaltrials.gov
Start Date
January 9, 2020
End Date
December 31, 2026
Last Updated
10 days ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medtronic Cardiac Surgery
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Device Safety

Time Frame: Procedural

Procedure- , device-related events and device deficiencies

Device performance

Time Frame: Procedural

Device Success

Study Sites (26)

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