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

Starting soon

Conditions studied: Cardiopulmonary Bypass Surgery

In brief

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 from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12/2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required 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 granted CE marking under the old practices can be used safely by patients throughout their lifecycle.

Key facts

Study ID

NCT07628907

Run by

Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

People needed

20

Starts

2026-07-01

Expected to finish

2026-10-01

Last updated by the study team

2026-06-05

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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