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

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 deemed clinically appropriate and sufficient. In this context, a minimum sample size is determined without considering an objective expectation or the Type I and Type II statistical errors accepted in the research.

The sample will be formed by including participants such that even for the option with the fewest patients operated on-among the four options comprising two operative procedures and two cannula types-there will be at least 5 cases. Since the selection of the appropriate cannula is determined by the surgeon based on the patient's condition and characteristics, this sample will, to some extent, attempt to reflect real-world data on cannula use on a small scale.

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 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

Exclusion Criteria:

• 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