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

NCT07628920 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2026-06-05

No results posted yet for this study

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

Interventions

DEVICE

Vent Catheter

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

Sponsors & Collaborators

  • Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.

    lead OTHER

Principal Investigators

  • Atıf Akçevin, Prof. Dr. · Koc University Hospital

  • Ozan Onur Balkanay, Prof. Dr. · İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-09-01
Completion
2026-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07628920 on ClinicalTrials.gov