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NCT Number: NCT07087639

Novel Venous Cannula Trial

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.

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Key information

Conditions

Cardiac Surgery Cardiopulmonary Bypass Heart Surgery Minimally Invasive Surgical Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Cecilia Hospital

Cotignola, RA, 48033, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-expanding Venous Cannula

Device

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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 outcomes

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

    Time frame: During the surgical procedure (Day 0)

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

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

    Time frame: During the surgical procedure (Day 0)

    Mean Pump Flow Indexed to Body Surface Area During CPB

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

    Time frame: During the surgical procedure (Day 0)

    Number of Cannulae Positioned in the Surgical Field

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

    Time frame: During the surgical procedure (Day 0)

    Number of Cannula Tip Displacements Detected by TTE/TEE

  5. Mean increase in free Hb measure during surgical procedure Unit of Measure: mg/dL

    Time frame: During the surgical procedure (Day 0)

    Mean Increase in Free Hemoglobin Levels

  6. Mean volume of infusion during surgical procedure Unit of Measure: mL

    Time frame: During the surgical procedure (Day 0)

    Mean Volume of Infusion Administered

  7. Mean volume of cardioplegic solution Unit of Measure: mL

    Time frame: During the surgical procedure (Day 0)

    Mean Volume of Cardioplegic Solution Administered

  8. Mean speed of aspirators during surgical procedure Unit of Measure: mL/min

    Time frame: During the surgical procedure (Day 0)

    Mean Speed of Aspirators Used

  9. Mean percentage of pump flow increase due to the patient's metabolic needs Unit of Measure: %

    Time frame: During the surgical procedure (Day 0)

    Mean Percentage Increase in Pump Flow Due to Metabolic Needs

  10. Mean volume of recovery blood re-administered during surgical procedure Unit of Measure: mL

    Time frame: During the surgical procedure (Day 0)

    Mean Volume of Recovery Blood Re-Administered

  11. Number of patients for whom blood concentrator was used Unit of Measure: Count (number of patients)

    Time frame: During the surgical procedure (Day 0)

    Number of Patients for Whom a Blood Concentrator Was Used

  12. Presence of echocardiographic abnormalities Unit of Measure: n (%)

    Time frame: During the surgical procedure (Day 0)

    Presence of echocardiographic abnormalities

  13. Number of correctly delivery and deployed Novel Venous Cannula Unit of Measure: Count (number of cannulae)

    Time frame: During the surgical procedure (Day 0)

    Number of Novel Venous Cannulae Correctly Delivered and Deployed

  14. Number of technical success without procedural SAE Unit of Measure: n (%)

    Time frame: 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.

  15. Number of deaths at 7 days after procedure Unit of Measure: Count (number of patients)

    Time frame: 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.

  16. Number of cardiovascular deaths at 7 days after procedure Unit of Measure: Count (number of patients)

    Time frame: 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.

  17. Number of cardiovascular SAEs at 7 days after procedure Unit of Measure: Count (number of patients)

    Time frame: 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.

  18. Number of stroke at 7 days after procedure Unit of Measure: Count (number of patients)

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

    Number of patients experiencing a clinically confirmed stroke within 7 days following the procedure.

  19. Number minor neurological disorder at 7 days after procedure Unit of Measure: Count (number of patients)

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

    Number of patients experiencing minor neurological disorders within 7 days following the procedure.

Sponsors and collaborators

Lead sponsor

Eurosets S.r.l.

Industry

Registry information

Official study title

Safety and Effectiveness Evaluation of Novel MICS Venous Cannula

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jul 28, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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