Novel Venous Cannula Trial

Eurosets S.r.l.42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Cardiac Surgery Heart Surgery Cardiopulmonary Bypass Minimally Invasive Surgical Procedures

Interventions

Self-expanding Venous CannulaDEVICE

The intervention consists of a self-expanding venous drainage cannula made of polyurethane and reinforced with a flexible metallic mesh. It is designed for transfemoral insertion during on-pump cardiac surgery, including minimally invasive procedures. Once positioned, the cannula expands to its functional diameter to facilitate efficient blood drainage into the extracorporeal circulation system. The configuration used in this study is 680/730 mm in length, 24 Fr, 3/8" diameter. The device is sterile, single-use, and is inserted once on the day of surgery (Day 0) and removed at the end of the procedure. The cannula is used continuously during cardiopulmonary bypass for a maximum duration of 6 hours and is not reused.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Maria Cecilia Hospital

Cotignola, RA, Italy

Outcomes

Primary Outcomes

Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure

Measurement of the mean pressure drop (in millimeters of mercury, mmHg) across the novel venous cannula required to maintain the target blood flow rate (liters per minute) during cardiopulmonary bypass in cardiac surgery patients.

Time frame: During the surgical procedure (Day 0)

Safety: the number of SAE with the Novel Venous Cannula during the standard surgical procedure

Number of serious adverse events (SAEs) occurring during the surgical procedure that are related or possibly related to the use of the novel venous cannula, including device-related complications, cardiovascular events, and other procedure-associated serious adverse events.

Time frame: From Day 0 (procedure day) to 7 days post-procedure

Secondary Outcomes

Venous Line Flow During Extracorporeal Circulation Unit of Measure: mL/min

Measurement of venous line flow during CPB to assess the drainage efficiency of the novel venous cannula.

Time frame: During the surgical procedure (Day 0)

Mean pump flow during extracorporeal circulation Unit of Measure: L/min/m²

Mean Pump Flow Indexed to Body Surface Area During CPB

Time frame: During the surgical procedure (Day 0)

Number of cannulae in the surgical field during surgical procedure Unit of Measure: Count (number)

Number of Cannulae Positioned in the Surgical Field

Time frame: During the surgical procedure (Day 0)

Number of cannula tip displacement as detected by TTE/TEE during surgical procedure Unit of Measure: n (%)

Data from ClinicalTrials.gov

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