Cardiopulmonary Bypass SurgeryNCT07628920
Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.
An observational study of Cardiopulmonary Bypass Surgery, run by Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş..
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiopulmonary Bypass Surgery
- What is being tested?
- Vent Catheter
- Type of treatment
- Medical device
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
Read the detailed description
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
- Conditions
- Cardiopulmonary Bypass Surgery
- Being tested
- Vent Catheter
- Keywords
- 'vent catheter', PMCF, Cardiopulmonary bypass surgery, ostial cannula, Left ventricule, PMCF Study, Ventricular vent, heart ventilation, cardioplegia cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vent CatheterDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be measured during the surgery up to 6 hours.
Presence of bleeding
It will be used the 5-likert scale.
Measured: It will be measured during the surgery up to 6 hours.
Manipulation during insertion
It will be used 5-likert scale.
Measured: It will be measured during the surgery up to 6 hours.
Catheter placement
It will be used the 5-likert scale.
Measured: It will be measured during the surgery up to 6 hours.
Catheter removal
It will be used the 5-likert scale.
Measured: 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.
Measured: 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.
Measured: It will be measured during the surgery up to 6 hours.
Blockage in the holes during emptying
It will be used 5-likert scale.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: It will be measured during the surgery up to 6 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary Bypass SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atıf Akçevin, Prof. Dr., Principal investigator, Koc University HospitalOzan Onur Balkanay, Prof. Dr., Study director, İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628920
- Sponsor's protocol ID
- CIP-33003
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-market Clinical Follow-up Study on the Performance and Safety of a Vent Catheter Used During Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT07628920
- Acronym / sponsor ID
- CIP-33003
- Conditions
- Cardiopulmonary Bypass Surgery
- Keywords
- 'vent catheter', PMCF, Cardiopulmonary bypass surgery, ostial cannula, Left ventricule, PMCF Study, Ventricular vent, heart ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.University, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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,
Key exclusion criteria (6 listed)
- • Patients with diseased or abnormal tissue in the catheter placement site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vent CatheterVent 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 | Device | – |
Primary outcome
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.
Presence of bleeding
Time frame: It will be measured during the surgery up to 6 hours.
It will be used the 5-likert scale.
Manipulation during insertion
Time frame: It will be measured during the surgery up to 6 hours.
It will be used 5-likert scale.
Catheter placement
Time frame: It will be measured during the surgery up to 6 hours.
It will be used the 5-likert scale.
Catheter removal
Time frame: It will be measured during the surgery up to 6 hours.
It will be used the 5-likert scale.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Atıf Akçevin, Prof. Dr. principal investigator
Koc University Hospital
Ozan Onur Balkanay, Prof. Dr. study director
İstanbul University-Cerrahpaşa Prof. Dr. Murat Dilmener Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Bypass Surgery, run by Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gizem ÖZDEMİR, Biomedical Engineer (+90 5346137760, gizemozdemir@kocyasa.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trauma effects (time frame: It will be measured during the surgery up to 6 hours.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.