Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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