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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiopulmonary Bypass Surgery
• Intervention / Treatment: Device: aortic root cannula

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 Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Gizem Özdemir, Biomedical Engineer; Phone Number: +90 5346137760; Email: gizemozdemir@kocyasa.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

1

Device: aortic root cannula; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: cardiopulmonary bypass; coronary artery; aortic root; antegrade cardioplegia; cardiopleagia cannula; aortic root cannula; aortic ventilation
• Other Study ID Numbers: CIP-33001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No