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NCT Number: NCT07628920

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

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

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Key information

Conditions

Cardiopulmonary Bypass Surgery

Sex eligibility

All sexes

Study type

Observational

About this study

Primary Endpoints The primary endpoints have been designed to encompass all clinical outcomes that characterize the device's performance. The evaluation items listed below, which are directly related to the Bıçakcılar Vent Catheter, will be measured using a Likert scale with values ranging from 1 to 5.

  • Presence of bleeding
  • Impact of trauma
  • Manipulation during insertion
  • Placement
  • Removal (including removal of the stylet, if applicable)
  • Conformity to intended use/Drainage capability
  • Blockage formation in the ports
  • Presence of residue
  • Effective use
  • Retention of shape

Secondary Endpoints Since factors such as the surgeon performing the operation, the perfusionist operating the heart-lung machine, and the patients' clinical characteristics may act as confounding variables, other variables affecting the primary endpoints will be identified through secondary endpoints.

  • General and demographic information
  • Concomitant diseases
  • Concomitant treatments
  • Biochemical findings
  • Echocardiographic findings
  • Total duration of the procedure
  • Type of procedure
  • Vital and cardiac assessments
  • Evaluations related to the Vent catheter
  • Perfusion evaluations
  • Cardioplegia evaluations
  • Data on adverse events and complications

Definition of Participants (Volunteers) / Study Population Patients for whom a decision has been made by their physician to undergo routine surgical procedures using cardiopulmonary bypass, and for whom the use of a vent catheter is planned during the procedure

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 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

Exclusion criteria

  • • 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

Treatment and study plan

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

Primary outcomes

  1. Trauma effects

    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.

  2. Presence of bleeding

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

    It will be used the 5-likert scale.

  3. Manipulation during insertion

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

    It will be used 5-likert scale.

  4. Catheter placement

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

    It will be used the 5-likert scale.

  5. Catheter removal

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

    It will be used the 5-likert scale.

  6. Removal of the stylet (If the catheter contains a stylet)

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

    It will be used the 5-likert scale.

  7. Suitability of the device for its intended use / emptying capability

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

    It will be used 5-likert scale.

  8. Blockage in the holes during emptying

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

    It will be used 5-likert scale.

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

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

    It will be used 5-likert scale.

  10. Was its use as a filler for air extraction effective?

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

    It will be used 5-likert scale.

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

    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 ÖZDEMİR, 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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