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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiopulmonary Bypass
• Intervention / Treatment: Device: coronary artery perfusion cannula

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Gizem Özdemir Clinical Evaluation Secialist, Biomedical Engineer; Phone Number: +90 5346137760; Email: gizemozdemir@kocyasa.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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 that is clinically appropriate and sufficient. In this context, a minimum sample size is being established without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be constructed by including participants such that, in a 4-option design with two types of operations and two types of cannulas, there will be at least 5 cases even for the option with the fewest patients operated on in consecutive operations.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of bleeding	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.	It will be measured during the operation up to 6 hours.
Impact of trauma	It will be used a 5-likert scale.	During the operation
Manipulation during placement	It will be used a 5-likert scale.	During the operation
Cannula leakage	It will be used a 5-likert scale.	During the operation

Collaborators and Investigators

• Sponsor: Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cardioplegia; Coronary artery perfusion; coronary ostium; cardioplegia cannula; antegrade cannula; antegrade cardioplegia
• Other Study ID Numbers: CIP-33004a

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No