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NCT Number: NCT07354841

Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

This is a two-phase study evaluating the Eurosets arterial and venous cannulas for use during cardiopulmonary bypass (CPB) procedures. Phase 1 is a pilot study focused on assessing cannula safety. Phase 2 is a pivotal study aimed at confirming safety and evaluating efficacy through comparison with Medtronic cannulas (control group).

The results will be compared for non-inferiority with those obtained using the control group cannulas.

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Key information

Conditions

Cardiac Surgery Aortic Valve Surgery Arterial Cannulation Cannulation Cardiopulmonary Bypass Coronary Surgery Coronary Surgery With Cardiopulmonary Bypass Heart Surgery Venous Cannulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anthea Hospital GVM Care & Research

Bari, BA, 70124, Italy

Location status: Recruiting

About this study

The Clinical Investigation is a Two Phases clinical investigation consisting of a pre-Market, Pilot, Interventional, not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) intended to be used during Cardiopulmonary Bypass (CPB) procedure followed by a pre-Market, Pivotal, Interventional, Randomized, Non- inferiority, Monocentric Investigation to confirm the Safety and evaluate the Performance of the same cannulas.

The aim of these investigations are: 1) to evaluate safety of Eurosets Venous Cannula and Arterial Cannula in patients subjected to CPB and 2) to evaluate the performance and safety of Arterial Cannula and Venous Cannula intended to be used during CPB procedure. The results obtained will be compared by non-inferiority to the results obtained by Medtronic cannulae (control group).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient is considered able and willing to provide written informed consent according to the ethically approved informed consent form;
  • Female and male patients aged ≥ 18;
  • Body weight between 60 and 120 kg;
  • Body surface area (BSA) between 1.5 and 2.5 m2;
  • Patients scheduled to undergo central cannulation for cardiopulmonary bypass (CPB) in elective surgery procedures (isolated coronary and/or aortic valve surgery).

Exclusion criteria

  • Emergency cases;
  • Re-do cardiac surgery procedure;
  • Diabetes mellitus;
  • Hematologic diseases or history of thrombophilia;
  • Pregnancy or breastfeeding;
  • Concomitant major cardiac procedures;
  • Active malignant/metastatic neoplasm of any type;
  • Presence of pneumothorax and/or pulmonary emphysema;
  • Significant central nervous system injury;
  • Current intracranial hemorrhage;
  • Immunosuppression;
  • Contraindication for therapeutic anticoagulation (e.g., heparin);
  • Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
  • Abnormal or pathological cannulation site;
  • Uncontrolled active bleeding;
  • Awaiting transplantation;
  • Requiring preoperative extracorporeal membrane oxygenation;
  • Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study.
  • Patient is taking part in another interventional clinical study;
  • Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.

Treatment and study plan

Eurosets Venous and Arterial Cannula

Device

Phase 1: Use of investigational Eurosets arterial and venous cannulas during CPB to assess safety and preliminary performance.The Arterial cannulae are designed for insertion in the ascending Aorta. For this Investigation the arterial cannula is reinforced-long curved with flange tip, 3/8" connector with luer lock, 24 Fr.The Venous Cannulae are designed to be used for vena cava and right atrium blood drainage during CPB surgery. For this Investigation the venous cannula is dual stage without connector, lighthouse tip, 32/40 Fr.

Phase 2: Use of investigational PVC arterial and venous cannulas during cardiopulmonary bypass (CPB) to confirm safety and evaluate performance compared to control group. For Investigation device: same of phase 1. For Control Group: the Arterial Cannula is EOPA (Medtronic), 24 Fr; the Venous Cannula is Two stage MC2 (Medtronic), 32/40 Fr.

Control Arterial and Venous Cannulas

Device

Phase 2: Use of commercially available arterial and venous cannulas as comparator devices to evaluate the performance of the investigational PVC Arterial and Venous Cannulas during cardiopulmonary bypass (CPB) procedures. the control cannulas are EOPA 24Fr (Medtronic) as Arterial Cannula and Two Stage MC2 32/40Fr (Medtronic) as Venous Cannula.

Primary outcomes

  1. Phase 1: Safety of Eurosets Arterial and Venous Cannulas

    Time frame: At Visit 1 (Pre and during surgical procedure), at Visit 2 (24 hours post-surgical procedure) and at Visit 3 (within 6-7 days post-surgical procedure)

    Number and type of adverse events over the duration of the investigation.

  2. Phase 2: Performance of Eurosets Arterial Cannulas

    Time frame: Time points during CPB: 1st: pre-clamping/CPB initiation, 2nd: pre-weaning

    For Arterial cannula: the performance of the Eurosets Arterial Cannulacerebral oximetry (rSO2) will be monitored during CPB using near infrared spectroscopy (NIRS). Delta rSO2 (will be calculated as the percentage) (rate of decrease of rSO2 from pre-clamping) will be compared to delta rSO2 of control arterial cannula.

  3. Phase 2: Performance of Eurosets Venous Cannulas

    Time frame: Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.

    For Venous cannula: the performance of the Eurosets Venous Cannula, Central Venous Pressure (CVP) values will be monitored during CPB. Results will be compared to control venous cannula.

Secondary outcomes

  1. Phase 1: Clinical Parameters collected for safety: pH

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters monitored with pH value

  2. Phase 1: Clinical Parameters collected for safety: pCO2

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: pCO2 recorded with mmHg

  3. Phase 1: Clinical Parameters collected for safety: pO2

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: pO2 recorded with mmHg

  4. Phase 1: Clinical Parameters collected for safety: Blood Flow

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: Blood flow recorded with L/min

  5. Phase 1: Clinical Parameters collected for safety: Mean arterial pressure (MAP)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: MAP recorded with mmHg

  6. Phase 1: Clinical Parameters collected for safety: Mixed venous oxygen saturation (SvO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: SvO2 recorded with percentage (%)

  7. Phase 1: Clinical Parameters collected for safety: Arterial oxygen saturation (SaO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: SaO2 monitored with percentage

  8. Phase 1: Clinical Parameters collected for safety: Vacuum level

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: Vacuum level monitored with mmHg

  9. Phase 1: Vital sign collected for safety: body temperature

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery), at Unscheduled Visit(s).

    Vital signs: Body Temperature recorded with Celsius degrees (T°)

  10. Phase 1: Vital sign collected for safety: Heart Rate

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: Heart Rate recorded with beats/min

  11. Phase 1: Vital Sign collected for safety: Blood Flow

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital Sign: Blood flow recorded with L/min

  12. Phase 1: Vital sign collected for safety: Diastolic pressure

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: Diastolic pressure recorded with mmHg

  13. Phase 1: Vital sign collected for safety: Sistolic pressure

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: Sistolic pressure recorded with mmHg

  14. Phase 1: Vital sign collected for safety: SpO2

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: SpO2 recorded with percentage (%)

  15. Phase 1: Device deficiencies/incidents collected for safety

    Time frame: At Visit 1 Day 1 (Day of surgery): pre-CPB; 1st time point: Pre-clamping/CPB initiation; 2nd time point: 10 minutes post-clamping; 3rd time point: 30 minutes post-clamping; (pre) weaning/decannulation.

    Device deficiencies/incidents: recorded with number of Device Deficiencies or Incidents

  16. Phase 1: Concomitant medications collected for safety

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Concomitant medications: Medications administered (dosage) during the study period.

  17. Phase 1: Drainage pressure collected for safety

    Time frame: At visit 1 Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping.

    Drainage pressure: venous pressure compared to blood flow recorded with mmHg

  18. Phase 1: Reinfusion pressure collected for safety

    Time frame: At visit 1 Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping.

    Reinfusion pressure: arterial pressure compared to blood flow recorded with mmHg

  19. Phase 1: Adequacy of tissue perfusion collected for safety

    Time frame: At Visit 1 Day 1 (Day of surgery): (pre) weaning/ decannulation

    Adequacy of tissue perfusion recorded with levels of blood lactate

  20. Phase 1: Patient's metabolic condition collected for safety: indexed oxygen delivery (DO2i )

    Time frame: At visit 1 Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition DO2i recorded with ml/min/m2

  21. Phase 1: Patient's metabolic condition collected for safety: oxygen consuption (VO2)

    Time frame: At visit 1 Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition VO2 recorded with ml/min

  22. Phase 1: Patient's metabolic condition collected for safety: oxygen extraction (O2ER)

    Time frame: At visit 1 Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition O2ER recorded with percentage (%)

  23. Phase 1: Patient's metabolic condition collected for safety: venous oxygen saturation (SvO2)

    Time frame: At visit 1 Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition SvO2 recorded with percentage (%)

  24. Phase 1: Patient's metabolic condition coillected for safety: arterial oxygen saturation (SaO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition SaO2 recorded with percentage (%)

  25. Phase 1: Drainage efficacy of the venous cannula collected for safety

    Time frame: At Visit 0 (from day -3 to day -1 of surgical procedure) and Visit 2 (24 hours post-surgical procedure)

    Drainage efficacy of the venous cannula recorded with levels of bilirubin

  26. Phase 1: Drainage efficacy of the venous cannula collected for safety

    Time frame: At Visit 0 (from day -3 to day -1 of surgical procedure) and Visit 2 (24 hours post-surgical procedure)

    Drainage efficacy of the venous cannula recorded with levels of creatinine

  27. Phase 1: Drainage efficacy of the venous cannula collected for safety

    Time frame: At Visit 0 (from day -3 to day -1 of surgical procedure) and Visit 2 (24 hours post-surgical procedure)

    Drainage efficacy of the venous cannula recorded with levels of transaminases

  28. Phase 1: Duration of CPB procedure and clamping collected for safety

    Time frame: At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation.

    Duration of CPB procedure and clamping recorded with Time (minutes)

  29. Phase 1: (de)cannulation difficulty collected for safety

    Time frame: At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation

    (de)cannulation difficulty recorded with 5-likert Scale (from 1 - very easy to 5 - very difficult) completed by the anesthesiologist/perfusionist/physician who performed the procedure at Visit 1.

  30. Phase 1: Integrity of arterial and venous cannula at decannulation collected for safety

    Time frame: At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation

    Integrity of arterial and venous cannula at decannulation will be evaluated by the anesthesiologist/perfusionist/physician who performed the procedure and recorded with YES or NO.

  31. Phase 1: Presence of clots or thrombi in arterial and venous cannula at decannulation collected for safety

    Time frame: At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation

    Presence of clots or thrombi in arterial and venous cannula at decannulation. The presence of clots or thrombi will be recorded with YES or NO on the eCRF.

  32. Phase 1: Hospitalization stay collected for safety

    Time frame: At Visit 3: Pre-discharge (within 6-7 days post-surgical procedure)

    The number of hospitalization days will be recorded up to patient discharge.

  33. Phase 2: Drainage pressure (Pdrain) collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Drainage pressure (Pdrain) recorded with mmHg. Results compared with control Venous Cannula.

  34. Phase 2: Reinfusion pressure (Pout) collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Reinfusion pressure recorded with mmHg. Results compared with control Arterial Cannula.

  35. Phase 2: Adequacy of tissue perfusion collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of surgery): (pre) weaning/decannulation.

    Adequacy of tissue perfusion recorded with levels of blood lactate. Results compared with control group

  36. Phase 2: Patient's metabolic condition collected for non-inferiority with control group: indexed oxygen delivery (DO2i)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition DO2i recorded with ml/min/m2. Results compared with control group.

  37. Phase 2: Patient's metabolic condition collected for non-inferiority with control group: oxygen consumption (VO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition VO2 recorded with ml/min. Results compared with control group.

  38. Phase 2: Patient's metabolic condition collected for non-inferiority with control group: oxygen extraction (O2ER)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition O2ER recorded with percentage (%). Results compared with control group.

  39. Phase 2: Patient's metabolic condition collected for non-inferiority with control group: venous oxygen saturation (SVO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition SVO2 recorded with percentage (%). Results compared with control group.

  40. Phase 2: Patient's metabolic condition collected for non-inferiority with control group: arterial oxygen ssaturation (SaO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Patient's metabolic condition SaO2 recorded with percentage (%). Results compared with control group.

  41. Phase 2: Drainage efficacy of the venous cannula collected for non-inferiority with control group

    Time frame: At screening/baseline (Visit 0): Within 3 days before the day of surgery. At Visit 2: 24 hours post-surgical procedure. At Visit 3: before discharge (6-7 days post-surgical procedure).

    Drainage efficacy of the venous cannula recorded with levels of bilirubin. Results compared with control group.

  42. Phase 2: Drainage efficacy of the venous cannula collected for non-inferiority with control group

    Time frame: At screening/baseline (Visit 0): Within 3 days before the day of surgery. At Visit 2: 24 hours post-surgical procedure. At Visit 3: before discharge (6-7 days post-surgical procedure).

    Drainage efficacy of the venous cannula recorded with levels of creatinine. Results compared with control group.

  43. Phase 2: Drainage efficacy of the venous cannula collected for non-inferiority with control group

    Time frame: At screening/baseline (Visit 0): Within 3 days before the day of surgery. At Visit 2: 24 hours post-CPB. At Visit 3: before discharge (6-7 days post-surgical procedure).

    Drainage efficacy of the venous cannula recorded with levels of transaminases. Results compared with control group.

  44. Phase 2: Duration of CPB procedure and clamping time collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.

    Duration of CPB procedure and clamping time recorded with Time (minutes). Results compared with control group.

  45. Phase 2: (de)cannulation difficulty collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.

    (de)cannulation difficulty recorded with 5-likert Scale (from 1 - very easy to 5 - very difficult) completed by the anesthesiologist/perfusionist/physician. Results compared with control group.

  46. Phase 2: Integrity of arterial and venous cannula at decannulation collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.

    Integrity of arterial and venous cannula at decannulation recorded with YES or NO.

  47. Phase 2: Presence of clots or thrombi in arterial and venous cannula at decannulation collected for non-inferiority with control group

    Time frame: At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.

    Presence of clots or thrombi in arterial and venous cannula at decannulation recorded with YES or NO on the eCRF. Results compared with control cannulae.

  48. Phase 2: Hospitalization stay collected for non-inferiority with control group

    Time frame: At Visit 3 (End of Study). Pre-discharge (6-7 days post-surgical procedure).

    Hospitalization stay recorded with number of hospitalization days. Results compared with control group

Other outcomes

  1. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pH

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters monitored with pH value

  2. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pCO2

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: pCO2 recorded with mmHg

  3. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pO2

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: pO2 recorded with mmHg

  4. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Bloof flow

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: Blood flow recorded with L/min

  5. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Mean arterial Pressure (MAP)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: MAP recorded with mmHg

  6. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Mixed venous oxygen saturation (SvO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: SvO2 recorded with percentage (%)

  7. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Arterial oxygen saturation (SaO2)

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: SaO2 monitored with percentage (%)

  8. Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Vaccum Level

    Time frame: At Visit 1. Day 1 (Day of surgery): 1st time point: Pre-clamping/CPB initiation, 2nd time point: 10 minutes post-clamping, 3rd time point: 30 minutes post-clamping, (pre) weaning/ decannulation.

    Clinical parameters: Vacuum level monitored with mmHg

  9. Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: Body temperature

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Description: Vital signs: Body Temperature recorded with Celsius degree (T°)

  10. Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: Heart Rate

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: Heart Rate recorded with beats/min

  11. Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: Blood flow

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital Sign: Blood flow recorded with L/min

  12. Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: diastolic pressure

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: Diastolic pressure recorded with mmHg

  13. Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: sistolic pressure

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: Sistolic pressure recorded with mmHg

  14. Safety Endpoint during Phase 2 (Pivotal). Monitoring of vital sign: SpO2

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Vital signs: SpO2 recorded with percentage (%)

  15. Safety Endpoint during Phase 2 (Pivotal): Monitoring of Device deficiencies/incidents

    Time frame: At Visit 1 Day 1 (Day of surgery): pre-CPB; 1st time point: Pre-clamping/CPB initiation; 2nd time point: 10 minutes post-clamping; 3rd time point: 30 minutes post-clamping; (pre) weaning/decannulation.

    Device deficiencies/incidents recorded with number of Device Deficiencies or Incidents

  16. Safety Endpoint during Phase 2 (Pivotal): Monitoring of adverse events, and serious adverse events unrelated to study device

    Time frame: At Visit 1 (Pre and during surgical procedure), at Visit 2 (24 hours post-surgical procedure) and at Visit 3 (within 6-7 days post-surgical procedure)

    Number and type of adverse events, and serious adverse events unrelated to study device over the duration of the investigation.

  17. Safety Endpoint during Phase 2 (Pivotal): Monitoring of concomitant medications

    Time frame: At Visit 0 (from day -3 to day -1), Day of Surgery - Visit 1 (Day 0), Visit 2 (24 hours after surgery), Visit 3 (6-7 days after surgery).

    Concomitant medications: Medications administered (dosage) during the study period.

Study contacts

Contact information is provided by the study sponsor or research team.

Prof. Giuseppe Nasso

CONTACT

[email protected]

+39 080 5644111

Sponsors and collaborators

Lead sponsor

Eurosets S.r.l.

Industry

Registry information

Official study title

A Two Phases Clinical Investigation Consisting of a Pre-Market, Pilot, Interventional, Not Randomized, Monocentric Investigation to Evaluate the Safety of PVC Arterial Cannula and PVC Venous Cannula (Class III Medical Devices) Intended to be Used During Cardiopulmonary Bypass (CPB) Procedure Followed by a Pre-Market, Pivotal, Interventional, Randomized, Non- Inferiority, Monocentric Investigation to Confirm the Safety and Evaluate the Performance of the Same Cannulas

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

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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