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

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.

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Key information

Conditions

Cardiopulmonary Bypass Surgery

Sex eligibility

All sexes

Study type

Observational

About this study

Primary Purpose To demonstrate the performance of the Bıçakcılar Aortic Root Cannula in patients for whom its use is planned, in accordance with the device's intended purpose as outlined in the user manual, taking into account the following aspects: bleeding, trauma, manipulation, placement and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its shape Secondary Objectives

To obtain observational data on secondary evaluation parameters (demographic data, concomitant diseases and treatments, biochemistry and echocardiography findings, vital and cardiological assessments, perfusion and cardioplegia assessments)
To evaluate the impact of the use of the Bıçakcılar Aortic Root Cannula on the development of adverse events and complications
To conduct post-market clinical follow-up of the Bıçakcılar Aortic Root Cannula

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

aortic root cannula

Device

The Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting. The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries.

Primary outcomes

Presence of bleeding

Time frame: It will be measured during the surgery 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

Time frame: It will be measured during the surgery up to 6 hours.

It will be used 5-likert scale.
Manipulation during placement

Time frame: It will be measured during the surgery up to 6 hours.

It will be used 5-likert scale.
Catheter removal

Time frame: It will be measured during the surgery up to 6 hours.

It will be used 5-likert scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Gizem Özdemir, Biomedical Engineer

CONTACT

[email protected]

+90 5346137760

Sponsors and collaborators

Lead sponsor

Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jun 5, 2026
Registry last updated: Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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