Cardiac Surgery, Cardiopulmonary Bypass, Heart Surgery, Minimally Invasive Surgical Procedures
Conditions
Keywords
Venous Cannula, Extracorporeal Circulation, Cardiopulmonary Bypass, Cardiac Surgery, Transfemoral Venous Cannulation, Minimally Invasive Cardiac Surgery (MICS), Medical Device, Pressure Drop, Serious Adverse Events (SAE), Device Safety, Device Performance, Open-label Clinical Trial, Single-arm Study, Monocentric Study, Self-expanding Cannula
Brief summary
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.
Detailed 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.
Interventions
DEVICESelf-expanding Venous Cannula
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.
Sponsors
Eurosets S.r.l.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
Open-label
Intervention model description
Open-label, non-randomized, monocentric, one arm clinical investigation with pre-marked medical device
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure | During the surgical procedure (Day 0) | 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. |
| Safety: the number of SAE with the Novel Venous Cannula during the standard surgical procedure | From Day 0 (procedure day) to 7 days post-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of echocardiographic abnormalities Unit of Measure: n (%) | During the surgical procedure (Day 0) | Presence of echocardiographic abnormalities |
| Mean pump flow during extracorporeal circulation Unit of Measure: L/min/m² | During the surgical procedure (Day 0) | Mean Pump Flow Indexed to Body Surface Area During CPB |
| Number of cannulae in the surgical field during surgical procedure Unit of Measure: Count (number) | During the surgical procedure (Day 0) | Number of Cannulae Positioned in the Surgical Field |
| Number of cannula tip displacement as detected by TTE/TEE during surgical procedure Unit of Measure: n (%) | During the surgical procedure (Day 0) | Number of Cannula Tip Displacements Detected by TTE/TEE |
| Mean increase in free Hb measure during surgical procedure Unit of Measure: mg/dL | During the surgical procedure (Day 0) | Mean Increase in Free Hemoglobin Levels |
| Mean volume of infusion during surgical procedure Unit of Measure: mL | During the surgical procedure (Day 0) | Mean Volume of Infusion Administered |
| Mean volume of cardioplegic solution Unit of Measure: mL | During the surgical procedure (Day 0) | Mean Volume of Cardioplegic Solution Administered |
| Mean speed of aspirators during surgical procedure Unit of Measure: mL/min | During the surgical procedure (Day 0) | Mean Speed of Aspirators Used |
| Venous Line Flow During Extracorporeal Circulation Unit of Measure: mL/min | During the surgical procedure (Day 0) | Measurement of venous line flow during CPB to assess the drainage efficiency of the novel venous cannula. |
| Mean volume of recovery blood re-administered during surgical procedure Unit of Measure: mL | During the surgical procedure (Day 0) | Mean Volume of Recovery Blood Re-Administered |
| Number of correctly delivery and deployed Novel Venous Cannula Unit of Measure: Count (number of cannulae) | During the surgical procedure (Day 0) | Number of Novel Venous Cannulae Correctly Delivered and Deployed |
| Number of technical success without procedural SAE Unit of Measure: n (%) | During the surgical procedure (Day 0) | Number of patients in which the device was used successfully without the occurrence of procedural serious adverse events during the procedure. |
| Number of deaths at 7 days after procedure Unit of Measure: Count (number of patients) | From Day 0 (procedure day) to 7 days post-procedure | Number of patients who die within 7 days following the surgical procedure involving the use of the novel venous cannula. |
| Number of cardiovascular deaths at 7 days after procedure Unit of Measure: Count (number of patients) | From Day 0 (procedure day) to 7 days post-procedure | Number of patients who experience cardiovascular-related death within 7 days following the surgical procedure. |
| Number of cardiovascular SAEs at 7 days after procedure Unit of Measure: Count (number of patients) | From Day 0 (procedure day) to 7 days post-procedure | Number of cardiovascular-related serious adverse events (SAEs) occurring within 7 days after the procedure. |
| Number of stroke at 7 days after procedure Unit of Measure: Count (number of patients) | From Day 0 (procedure day) to 7 days post-procedure | Number of patients experiencing a clinically confirmed stroke within 7 days following the procedure. |
| Number minor neurological disorder at 7 days after procedure Unit of Measure: Count (number of patients) | From Day 0 (procedure day) to 7 days post-procedure | Number of patients experiencing minor neurological disorders within 7 days following the procedure. |
| Mean percentage of pump flow increase due to the patient's metabolic needs Unit of Measure: % | During the surgical procedure (Day 0) | Mean Percentage Increase in Pump Flow Due to Metabolic Needs |
| Number of patients for whom blood concentrator was used Unit of Measure: Count (number of patients) | During the surgical procedure (Day 0) | Number of Patients for Whom a Blood Concentrator Was Used |
Countries
Italy
Outcome results
None listed