Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery

Обзор

Prior to the implementation of the Medical Device Regulation (MDR), the clinical evaluation of existing devices was conducted by Notified Bodies (NBs) based on clinical data from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12/2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required to verify the performance and safety of the device in accordance with its intended use throughout its lifecycle. Consequently, PMCF studies are being planned to demonstrate that medical devices previously granted CE marking under the old practices can be used safely by patients throughout their lifecycle.

Подробное описание

Primary Purpose To demonstrate the performance of the Bıçakcılar Aortic Root Cannula in patients for whom its use is planned, in accordance with the device's intended purpose as outlined in the user manual, taking into account the following aspects: bleeding, trauma, manipulation, placement and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its shape Secondary Objectives

* To obtain observational data on secondary evaluation parameters (demographic data, concomitant diseases and treatments, biochemistry and echocardiography findings, vital and cardiological assessments, perfusion and cardioplegia assessments) * To evaluate the impact of the use of the Bıçakcılar Aortic Root Cannula on the development of adverse events and complications * To conduct post-market clinical follow-up of the Bıçakcılar Aortic Root Cannula

Вмешательства

• Устройство aortic root cannula
  The Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting. The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries.

Первичные конечные точки

• Presence of bleeding [Срок оценки: It will be measured during the surgery up to 6 hours.]
• Impact of trauma [Срок оценки: It will be measured during the surgery up to 6 hours.]
• Manipulation during placement [Срок оценки: It will be measured during the surgery up to 6 hours.]
• Catheter removal [Срок оценки: It will be measured during the surgery up to 6 hours.]

Критерии участия

Критерии включения

• Patients who have consulted the Department of Cardiovascular Surgery and for whom the physician has decided to perform heart surgery using the cardiopulmonary bypass technique,

• Patients for whom the use of an aortic root cannula is planned during surgery
• Patients who, prior to surgery, have provided consent in the "Cardiovascular Surgery Department Information and Consent Form, Use of Patient Data for Educational and Research Purposes" section regarding the use of their data

Критерии исключения

• Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel)

• Patients with calcified aorta, aortic valve insufficiency, occluded coronary arteries, the presence of adventitia or plaques, fibrosis in the aortic wall, or low arterial pressure Patients who have difficulty understanding the study and complying with it
• Patients who may pose a conflict of interest (e.g., relatives of employees of sponsoring companies)
• Patients who have participated in any clinical trial within the past 30 days

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07628907 · CIP-33001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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