This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous cannulation. The investigation aims to assess the pressure drop across the cannula during extracorporeal circulation and the incidence of serious adverse events associated with its use. A total of 42 participants will be enrolled.

This clinical investigation evaluates a Novel Venous Cannula intended for drainage of venous blood during extracorporeal circulation in cardiac surgery. The cannula is made of polyurethane and includes a flexible metallic mesh that allows it to collapse during insertion and expand in situ. It is designed for single use, sterile, and is introduced using a dedicated insertion kit.

The study is a non-randomized, open-label, monocentric, single-arm investigation involving 42 adult patients undergoing elective cardiac surgery requiring transfemoral venous cannulation. The investigation includes three visits: a screening visit (from Day -7 to Day -1), the procedure day (Day 0), and a follow-up visit at Day 7 ± 3 days.

The primary effectiveness outcome is the mean pressure drop (mm Hg) across the cannula required to maintain the target flow rate during surgery. The primary safety outcome is the number of serious adverse events (SAEs) related to the use of the investigational device.

Secondary outcomes include several efficacy-related parameters (e.g., venous line flow, pump flow, cannula positioning, volume of infusion, cardioplegic solution usage, and others), as well as safety outcomes including mortality, cardiovascular events, and neurological complications at 7 days post-procedure.

There is no control group in this study.

Inclusion Criteria:

• Age > 18 years
• Informed consent obtained
• Hospitalised patients undergoing transfemoral venous cannulation for on pump cardiac surgery procedure

Exclusion Criteria:

• Active bleeding
• Need of ECLS
• Low platelet count (<150,000)
• Any clinical conditions that contra-indicate the anti-coagulation
• Any clinical condition that, in the opinion of the investigator, may interfere with the procedure
• Subjects participating in any other clinical trial or investigation with a medical device within 3 months before Assessment visit

De-identified individual participant data (IPD) may be made available to qualified researchers upon reasonable request to the Sponsor, after study completion and publication of the primary results. Each request will be reviewed on a case-by-case basis in accordance with applicable data protection laws, including the EU General Data Protection Regulation (GDPR) 2016/679, and ethical considerations. Access will be granted through a controlled process to ensure the protection of participant confidentiality.

IPD and supporting information will be available starting 6 months after publication of the primary study results, and will remain accessible for 5 years thereafter.

De-identified individual participant data (IPD) and supporting documents (such as study protocol, statistical analysis plan, and clinical study report) will be available to qualified researchers upon reasonable request.

Requestors must submit a research proposal describing the intended use of the data. Access will be granted after approval by the Sponsor to ensure compliance with ethical standards and data protection regulations, including GDPR.

Data will be shared through a secure data-sharing platform or via encrypted transfer under a data use agreement that protects participant confidentiality and limits use to the approved research purposes.

Open-label