Novel Venous Cannula Trial

Eurosets

Status: Completed

Conditions: Heart Surgery; Cardiac Surgery; Minimally Invasive Surgical Procedures; Cardiopulmonary Bypass

Treatments: Device: Self-expanding Venous Cannula

Study type: Interventional

Funder types: Industry

Identifiers

NCT07087639

DE-51-20

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

Experimental Arm - Novel Self-expanding Venous Cannula

Experimental group

Description:

Participants in this arm will undergo transfemoral venous cannulation using the Novel Self-expanding Venous Cannula during on-pump cardiac surgery procedures. The investigational device is a single-use, sterile polyurethane cannula reinforced with a flexible metallic mesh that allows self-expansion once deployed into the vessel. The device is intended to facilitate efficient venous drainage as part of the extracorporeal circulation system. The study aims to evaluate the device's performance in terms of pressure drop and safety profile.

Treatment:

Device: Self-expanding Venous Cannula