Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.

NCT07628920 | Not Yet Recruiting

• 1 other identifier: CIP-33003
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 obtained from equivalent devices, and CE certificates were issued for devices exhibiting similar characteristics. Following the transition to the MDR, the European Commission's Guidance Document MEDDEV 2.12/2 highlighted that Notified Bodies, which issued CE certificates under the previous regime, must now organize Post-Marketing Clinical Follow-up (PMCF) studies 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 marked with the CE mark under the old regulations are used safely for patients throughout their lifecycle. Primary Objective To demonstrate the performance of the Bıçakcılar Vent Catheter 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, passage manipulation, insertion and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its form

Conditions

Cardiopulmonary Bypass Surgery

Keywords

'vent catheter'; PMCF; Cardiopulmonary bypass surgery; ostial cannula; Left ventricule; PMCF Study; Ventricular vent; heart ventilation; cardioplegia cannula

Outcome Measures

Primary Outcomes (11)

• Trauma effects

  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 surgery up to 6 hours.

• Presence of bleeding

  It will be used the 5-likert scale.

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

• Manipulation during insertion

  It will be used 5-likert scale.

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

• Catheter placement

  It will be used the 5-likert scale.

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

• Catheter removal

  It will be used the 5-likert scale.

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

• Removal of the stylet (If the catheter contains a stylet)

  It will be used the 5-likert scale.

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

• Suitability of the device for its intended use / emptying capability

  It will be used 5-likert scale.

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

• Blockage in the holes during emptying

  It will be used 5-likert scale.

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

• Was there any residue left on the catheter surface after the removal procedure was completed?

  It will be used 5-likert scale.

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

• Was its use as a filler for air extraction effective?

  It will be used 5-likert scale.

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

• Has the device retained its pre-operation form? (Evaluate for deformation, bending, or fractures)

  It will be used 5-likert scale.

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

Interventions

Vent Catheter DEVICE

Vent catheters have been used for many years in surgeries performed using cardiopulmonary bypass. Even after cardioplegic arrest has begun, blood continues to return to the right heart from the bronchial circulation, the Thesbian vascular system, and the coronary sinus; unless ventilated, it finds its way to the left ventricle, causing distension and tissue damage, respectively. A ventilation catheter must be used in any situation where the volume of blood returning to the heart chambers cannot be expelled. Vent catheters are used during cardiopulmonary bypass procedures for the surgical treatment of congenital and/or acquired heart and major vascular diseases in patients of all age groups to reduce pressure in the left ventricle and facilitate ventilation. Vent catheters are used as suction catheters to assist in completely draining blood from the heart. Therefore, Bıçakcılar Vent Catheters are designed to be used during cardiopulmonary bypass to reduce pressure in the heart chambers

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients with diseased or abnormal tissue at the catheter insertion site * Patients with intracardiac and/or major intravascular thrombi and/or masses * Patients with left atrial/ventricular myxoma * Patients who have difficulty understanding or complying with the study * Patients who may present 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

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 a vent catheter is planned during surgery
• Patients who, in the "Use of Patient Data for Educational and Research Purposes" section of the Department of Cardiovascular Surgery Informed Consent Form, have given permission for their data to be used

You may not qualify if:

• Patients with diseased or abnormal tissue in the catheter placement site
• Patients with intracardiac and/or major intravascular thrombi and/or masses
• Patients with left atrial/ventricular myxoma
• Patients who have difficulty understanding or complying with the study
• 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

Sponsors & Collaborators

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

Study Officials

• Atıf Akçevin, Prof. Dr.

  Koc University Hospital

  PRINCIPAL INVESTIGATOR

• Ozan Onur Balkanay, Prof. Dr.

  İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital

  STUDY DIRECTOR

Central Study Contacts

Gizem ÖZDEMİR, Biomedical Engineer

CONTACT

+90 5346137760; gizemozdemir@kocyasa.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06