Prior to the implementation of the Medical Device Regulation (MDR), clinical evaluation of older devices was carried out by Notified Bodies (MBs) based on clinical data obtained from equivalent devices, and CE certification was granted to devices exhibiting similar characteristics. Following the transition to the MDR, the European Union Commission's MEDDEV 2.12/2 guidance emphasizes that MBs, which issued CE certificates according to previous practices, should organize Post Marketing Clinical Follow-up (PMCF) studies to verify the performance and safety of the device throughout its lifecycle in accordance with its intended use for which it bears the CE mark. Thus, PMCF studies are planned to demonstrate that medical devices that were previously CE marked according to previous practices are used safely for patients throughout their lifecycles.
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 coronary artery perfusion 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
Patients with ostial calcification and/or an ostium that is too small for the cannula tip to fit through,
Patients known to have hypersensitivity to any of the materials used in the device components
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 the sponsoring company)
The aim of this study is not to prove a hypothesis defined by a specific objective-numerical expectation, but rather to compile the various outcomes resulting from the use of a medical device using data obtained from all cases collected within a timeframe that is clinically appropriate and sufficient. In this context, a minimum sample size is being established without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be constructed by including participants such that, in a 4-option design with two types of operations and two types of cannulas, there will be at least 5 cases even for the option with the fewest patients operated on in consecutive operations.
Other
Prospective
coronary artery perfusion cannula
DeviceThe Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery.
Presence of bleeding
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.
Impact of trauma
It will be used a 5-likert scale.
Manipulation during placement
It will be used a 5-likert scale.
Cannula leakage
It will be used a 5-likert scale.
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