Post-Market Clinical Follow-up Study on the Performance and Safety of the Aortic Root Cannula Used in Cardiopulmonary Bypass Surgery

NCT07628907 | Not Yet Recruiting

• 1 other identifier: CIP-33001
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiopulmonary Bypass Surgery

Keywords

aortic root; cardiopleagia cannula; aortic root cannula; aortic ventilation; cardiopulmonary bypass; antegrade cardioplegia; coronary artery

Outcome Measures

Primary Outcomes (4)

• 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.

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

• Impact of trauma

  It will be used 5-likert scale.

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

• Manipulation during placement

  It will be used 5-likert scale.

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

• Catheter removal

  It will be used 5-likert scale.

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

Study Arms (1)

1

1

Device: aortic root cannula

Interventions

aortic root cannula DEVICE

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.

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bıçakcılar Tıbbi Cihazlar Sanayi ve Ticaret A.Ş.: lead

Central Study Contacts

Gizem Özdemir, Biomedical Engineer

CONTACT

+90 5346137760; gizemozdemir@kocyasa.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: June 5, 2026

Record last verified: 2026-06