Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Use… (NCT07628907) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery
20 participantsStarted 2026-07-01
Plain-language 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. 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of bleeding
Timeframe: It will be measured during the surgery up to 6 hours.
2
Impact of trauma
Timeframe: It will be measured during the surgery up to 6 hours.
3
Manipulation during placement
Timeframe: It will be measured during the surgery up to 6 hours.
4
Catheter removal
Timeframe: It will be measured during the surgery up to 6 hours.
Trial details
NCT IDNCT07628907
SponsorBıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.