Cardiopulmonary Bypass SurgeryNCT07628907
Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery
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 from equivalent devices, and CE marking was granted to devices demonstrating 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?
- aortic root cannula
- Type of treatment
- Medical device
- How many people
- 20 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: 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 deemed clinically appropriate and sufficient. In this context, a minimum sample size is determined without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be formed by including participants such that even for the option with the fewest patients operated on-among the four options comprising two operative procedures and two cannula types-there will be at least 5 cases. Since the selection of the appropriate cannula is determined by the surgeon based on the patient's condition and characteristics, this sample will, to some extent, attempt to reflect real-world data on cannula use on a small scale.
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 an aortic root 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
Who cannot join
- Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel)
- Patients with calcified aorta, aortic valve insufficiency, occluded coronary arteries, the presence of adventitia or plaques, fibrosis in the aortic wall, or low arterial pressure 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 sponsoring companies)
- 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 from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12/2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required 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 granted CE marking under the old practices can be used safely by patients throughout their lifecycle.
Read the detailed description
Primary Purpose To demonstrate the performance of the Bıçakcılar Aortic Root Cannula 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, manipulation, placement and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its shape Secondary Objectives
- To obtain observational data on secondary evaluation parameters (demographic data, concomitant diseases and treatments, biochemistry and echocardiography findings, vital and cardiological assessments, perfusion and cardioplegia assessments)
- To evaluate the impact of the use of the Bıçakcılar Aortic Root Cannula on the development of adverse events and complications
- To conduct post-market clinical follow-up of the Bıçakcılar Aortic Root Cannula
- Conditions
- Cardiopulmonary Bypass Surgery
- Being tested
- aortic root cannula
- Keywords
- aortic root, cardiopleagia cannula, aortic root cannula, aortic ventilation, cardiopulmonary bypass, antegrade cardioplegia, coronary artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aortic root cannulaDevice
The Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting. The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries.
| Study group | Role | What they receive |
|---|---|---|
| 1 | 1 Receives: Device: aortic root cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: It will be measured during the surgery up to 6 hours.
Impact of trauma
It will be used 5-likert scale.
Measured: It will be measured during the surgery up to 6 hours.
Manipulation during placement
It will be used 5-likert scale.
Measured: It will be measured during the surgery up to 6 hours.
Catheter removal
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07628907
- Sponsor's protocol ID
- CIP-33001
- 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 the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery
- ClinicalTrials.gov ID
- NCT07628907
- Acronym / sponsor ID
- CIP-33001
- Conditions
- Cardiopulmonary Bypass Surgery
- Keywords
- aortic root, cardiopleagia cannula, aortic root cannula, aortic ventilation, cardiopulmonary bypass, antegrade cardioplegia, coronary artery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 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 from equivalent devices, and CE marking was granted to devices demonstrating similar characteristics. Following the transition to the MDR, the European Commission's Guideline MEDDEV 2.12/2 noted that, compared to previous practices, Notified Bodies issuing CE certificates must verify the performance and safety of the device throughout its lifecycle in accordance with its intended use by conducting Post Marketing Clinical Follow-up (PMCF) studies are required 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 granted CE marking under the old practices can be used safely by patients throughout their lifecycle.
Detailed description
Primary Purpose To demonstrate the performance of the Bıçakcılar Aortic Root Cannula 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, manipulation, placement and removal, compliance with the intended use, occlusion, retention of debris, effective use, and maintenance of its shape Secondary Objectives
- To obtain observational data on secondary evaluation parameters (demographic data, concomitant diseases and treatments, biochemistry and echocardiography findings, vital and cardiological assessments, perfusion and cardioplegia assessments)
- To evaluate the impact of the use of the Bıçakcılar Aortic Root Cannula on the development of adverse events and complications
- To conduct post-market clinical follow-up of the Bıçakcılar Aortic Root Cannula
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: aortic root cannula1 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 deemed clinically appropriate and sufficient. In this context, a minimum sample size is determined without considering an objective expectation or the Type I and Type II statistical errors accepted in the research. The sample will be formed by including participants such that even for the option with the fewest patients operated on-among the four options comprising two operative procedures and two cannula types-there will be at least 5 cases. Since the selection of the appropriate cannula is determined by the surgeon based on the patient's condition and characteristics, this sample will, to some extent, attempt to reflect real-world data on cannula use on a small scale.
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 (4 listed)
- Patients known to have hypersensitivity to any of the materials used in the device components (PVC, ABS, stainless steel)
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 |
|---|---|---|
| aortic root cannulaThe Aortic Root Cannula and Vented Aortic Root Cannula are indicated for the administration of cardioplegic solutions during cardiac surgical procedures such as coronary artery bypass grafting, aortic valve replacement, mitral valve replacement, double valve replacement, and aortic valve replacement combined with coronary artery bypass grafting. The Aortic Root Cannula (35 cm) is indicated for use in minimally invasive surgeries. | Device | 1 |
Primary outcome
Presence of bleeding
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.
Impact of trauma
Time frame: It will be measured during the surgery up to 6 hours.
It will be used 5-likert scale.
Manipulation during placement
Time frame: It will be measured during the surgery up to 6 hours.
It will be used 5-likert scale.
Catheter removal
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.
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 4 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 Özdemir, 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?
Presence of bleeding (time frame: It will be measured during the surgery up to 6 hours.). The study lists 4 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.