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 obtained from equivalent devices, and CE certificates were issued for devices exhibiting similar characteristics. Following the transition to the MDR, the European Commission's Guidance Document MEDDEV 2.12/2 highlighted that Notified Bodies, which issued CE certificates under the previous regime, must now organize Post-Marketing Clinical Follow-up (PMCF) studies 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 marked with the CE mark under the old regulations are used safely for patients throughout their lifecycle.
Primary Objective To demonstrate the performance of the Bıçakcılar Vent Catheter 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, passage manipulation, insertion and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its form
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 a vent catheter is planned during surgery
Patients who, in the "Use of Patient Data for Educational and Research Purposes" section of the Department of Cardiovascular Surgery Informed Consent Form, have given permission for their data to be used
• Patients with diseased or abnormal tissue in the catheter placement site
Patients with intracardiac and/or major intravascular thrombi and/or masses
Patients with left atrial/ventricular myxoma
Patients who have difficulty understanding or complying with the study
* Patients with diseased or abnormal tissue at the catheter insertion site * Patients with intracardiac and/or major intravascular thrombi and/or masses * Patients with left atrial/ventricular myxoma * Patients who have difficulty understanding or complying with the study * Patients who may present a conflict of interest (e.g., relatives of employees of the sponsoring company) * Patients who have participated in any clinical trial within the past 30 days
Other
Prospective
Vent Catheter
DeviceVent catheters have been used for many years in surgeries performed using cardiopulmonary bypass. Even after cardioplegic arrest has begun, blood continues to return to the right heart from the bronchial circulation, the Thesbian vascular system, and the coronary sinus; unless ventilated, it finds its way to the left ventricle, causing distension and tissue damage, respectively. A ventilation catheter must be used in any situation where the volume of blood returning to the heart chambers cannot be expelled. Vent catheters are used during cardiopulmonary bypass procedures for the surgical treatment of congenital and/or acquired heart and major vascular diseases in patients of all age groups to reduce pressure in the left ventricle and facilitate ventilation. Vent catheters are used as suction catheters to assist in completely draining blood from the heart. Therefore, Bıçakcılar Vent Catheters are designed to be used during cardiopulmonary bypass to reduce pressure in the heart chambers
Trauma effects
Primary endpoints are structured to encompass all clinical use outcomes characterizing device performance. Evaluation items directly related to the Bıçakcılar Vent Catheter will be measured using a Likert scale with values ranging from 1 to 5.
Presence of bleeding
It will be used the 5-likert scale.
Manipulation during insertion
It will be used 5-likert scale.
Catheter placement
It will be used the 5-likert scale.
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