Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Sponsor
Medtronic Cardiac Surgery (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04241328
Collaborator
(none)
5,000
11
71.7
454.5
6.3

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

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    SYMBIOSIS Post-Market Registry
    Actual Study Start Date :
    Jan 9, 2020
    Anticipated Primary Completion Date :
    Dec 30, 2025
    Anticipated Study Completion Date :
    Dec 30, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Device Safety [Procedural]

      Procedure- , device-related events and device deficiencies

    2. Device performance [Procedural]

      Device Success

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    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.
    Responsible Party:
    Medtronic Cardiac Surgery
    ClinicalTrials.gov Identifier:
    NCT04241328
    Other Study ID Numbers:
    • MDT19022PMF001
    First Posted:
    Jan 27, 2020
    Last Update Posted:
    Aug 15, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 15, 2022