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Набира участници NCT04241328

Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Заболявания: Cardiovascular Diseases

Спонсор: Medtronic Cardiac Surgery

Налично на: БГ
Обобщение
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.
Описание
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
Кой може да участва
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
Места на провеждане 14
Австрия (1)
AKH Wien
Vienna
Белгия (2)
Ziekenhuis Oost-Limburg
Genk
UZ Leuven
Leuven
Франция (2)
CHU d'Angers
Angers
COMPLETED
Clinique Claude Bernard
Metz
TERMINATED
Германия (3)
Uniklinik RWTH Aachen
Aachen
Herz- und Diabeteszentrum NRW
Bad Oeynhausen
Deutsches Herzzentrum München
Munich
Гърция (1)
Onassis Hospital
Athens
ACTIVE_NOT_RECRUITING
Нидерландия (3)
Catharina Ziekenhuis
Eindhoven
COMPLETED
Maastricht University Medical Center (MUMC+)
Maastricht
ACTIVE_NOT_RECRUITING
St. Antonius Ziekenhuis
Nieuwegein
Норвегия (1)
Haukeland Universitetssjukehus
Bergen
Испания (1)
Hospital Clinic Barcelona
Barcelona
COMPLETED
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Здрави доброволци
Не
Начална дата
09.01.2020
Крайна дата
31.12.2026
Регистрационен номер
NCT04241328
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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