Cardiopulmonary Bypass
Conditions
Keywords
Coronary artery perfusion, coronary ostium, cardioplegia, cardioplegia cannula, antegrade cannula, antegrade cardioplegia
Brief summary
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.
Interventions
DEVICEcoronary artery perfusion cannula
The Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery.
Sponsors
Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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) * Patients who have participated in any clinical trial within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of bleeding | It will be measured during the operation up to 6 hours. | 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 | During the operation | It will be used a 5-likert scale. |
| Manipulation during placement | During the operation | It will be used a 5-likert scale. |
| Cannula leakage | During the operation | It will be used a 5-likert scale. |
Contacts
CONTACTGizem Özdemir Clinical Evaluation Secialist, Biomedical Engineer
Outcome results
None listed