RecruitingNot ApplicableNCT07354841

Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

A Two Phases Clinical Investigation Consisting of a Pre-Market, Pilot, Interventional, Not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) Intended to be Used During Cardiopulmonary Bypass (CPB) Procedure Followed by a Pre-Market, Pivotal, Interventional, Randomized, Non- Inferiority, Monocentric Investigation to Confirm the Safety and Evaluate the Performance of the Same Cannulas

Sponsor

Eurosets S.r.l.

Enrollment

80 participants

Start Date

Oct 21, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Surgery Cardiac Surgery Cardiopulmonary Bypass Cannulation Coronary Surgery Aortic Valve Surgery Venous Cannulation

Summary

This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group). The results will be compared for non-inferiority with those obtained using the control group cannulas.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;
Female and male patients aged ≥ 18;
Body weight between 60 and 120 kg;
Body surface area (BSA) between 1.5 and 2.5 m2;
Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and/or aortic valve surgery).

Exclusion Criteria20

Emergency cases;
Re-do cardiac surgery procedure;
Diabetes mellitus;
Hematologic diseases or history of thrombophilia;
Pregnancy or breastfeeding;
Concomitant major cardiac procedures;
Active malignant/metastatic neoplasm of any type;
Presence of pneumothorax and/or pulmonary emphysema;
Significant central nervous system injury;
Current intracranial hemorrhage;
Immunosuppression;
Contraindication for therapeutic anticoagulation (e.g., heparin);
Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
Abnormal or pathological cannulation site;
Uncontrolled active bleeding;
Awaiting transplantation;
Requiring preoperative extracorporeal membrane oxygenation;
Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study.
Patient is taking part in another interventional clinical study;
Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.

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Interventions

DEVICEEurosets Venous and Arterial Cannula

Phase 1: Use of investigational Eurosets arterial and venous cannulas during CPB to assess safety and preliminary performance.The Arterial cannulae are designed for insertion in the ascending Aorta. For this Investigation the arterial cannula is reinforced-long curved with flange tip, 3/8" connector with luer lock, 24 Fr.The Venous Cannulae are designed to be used for vena cava and right atrium blood drainage during CPB surgery. For this Investigation the venous cannula is dual stage without connector, lighthouse tip, 32/40 Fr. Phase 2: Use of investigational PVC arterial and venous cannulas during cardiopulmonary bypass (CPB) to confirm safety and evaluate performance compared to control group. For Investigation device: same of phase 1. For Control Group: the Arterial Cannula is EOPA (Medtronic), 24 Fr; the Venous Cannula is Two stage MC2 (Medtronic), 32/40 Fr.

DEVICEControl Arterial and Venous Cannulas

Phase 2: Use of commercially available arterial and venous cannulas as comparator devices to evaluate the performance of the investigational PVC Arterial and Venous Cannulas during cardiopulmonary bypass (CPB) procedures. the control cannulas are EOPA 24Fr (Medtronic) as Arterial Cannula and Two Stage MC2 32/40Fr (Medtronic) as Venous Cannula.