Post-market Clinical Follow-up Study on the Performance and Safety of Coronary Artery Perfusion Cannula Used During Cardiopulmonary Bypass

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.

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Key information

Conditions

Cardiopulmonary Bypass

Sex eligibility

All sexes

Study type

Observational

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 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

Treatment and study plan

coronary artery perfusion cannula

Device

The Coronary Artery Perfusion Cannula is designed for the direct administration of cardioplegic solution into the coronary arteries during cardiopulmonary bypass surgery.

Primary outcomes

Presence of bleeding

Time frame: 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

Time frame: During the operation

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

Time frame: During the operation

It will be used a 5-likert scale.
Cannula leakage

Time frame: During the operation

It will be used a 5-likert scale.

Study contacts

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

Gizem Özdemir Clinical Evaluation Secialist, 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 2, 2026
Registry last updated: Jun 2, 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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