Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Cardiopulmonary Bypass; Heart Surgery; Aortic Valve Surgery; Cannulation; Coronary Surgery With Cardiopulmonary Bypass; Coronary Surgery; Arterial Cannulation; Venous Cannulation
• Intervention / Treatment: Device: Eurosets Venous and Arterial Cannula; Device: Control Arterial and Venous Cannulas

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Prof. Giuseppe Nasso; Phone Number: +39 080 5644111; Email: gnasso@libero.it

Study Locations

• Italy
  • BA
    • Bari, BA, Italy, 70124
      • Recruiting
      • Anthea Hospital GVM Care & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Emergency cases;
2. Re-do cardiac surgery procedure;
3. Diabetes mellitus;
4. Hematologic diseases or history of thrombophilia;
5. Pregnancy or breastfeeding;
6. Concomitant major cardiac procedures;
7. Active malignant/metastatic neoplasm of any type;
8. Presence of pneumothorax and/or pulmonary emphysema;
9. Significant central nervous system injury;
10. Current intracranial hemorrhage;
11. Immunosuppression;
12. Contraindication for therapeutic anticoagulation (e.g., heparin);
13. Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
14. Abnormal or pathological cannulation site;
15. Uncontrolled active bleeding;
16. Awaiting transplantation;
17. Requiring preoperative extracorporeal membrane oxygenation;
18. 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.
19. Patient is taking part in another interventional clinical study;
20. Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eurosets Arterial and Venous Cannula; Phase 1: All enrolled subjects will undergo cardiopulmonary bypass using the investigational Eurosets arterial and venous cannulas to evaluate the safety. Phase 2: Participants will undergo cardiopulmonary bypass using the investigational Eurosets arterial and venous cannulas to confirm safety and to evaluate the performance.	Device: Eurosets Venous and Arterial Cannula; 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.
Active Comparator: Control Arterial and Venous Cannula; Phase 2: Participants will undergo cardiopulmonary bypass using commercially available arterial and venous cannulas currently used in standard clinical practice.	Device: Control Arterial and Venous Cannulas; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Safety of Eurosets Arterial and Venous Cannulas	Number and type of adverse events over the duration of the investigation.	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)
Phase 2: Performance of Eurosets Arterial Cannulas	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.	Time points during CPB: 1st: pre-clamping/CPB initiation, 2nd: pre-weaning
Phase 2: Performance of Eurosets Venous Cannulas	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.	Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1: Clinical Parameters collected for safety: pH	Clinical parameters monitored with pH value	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.
Phase 1: Clinical Parameters collected for safety: pCO2	Clinical parameters: pCO2 recorded with mmHg	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.
Phase 1: Clinical Parameters collected for safety: pO2	Clinical parameters: pO2 recorded with mmHg	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.
Phase 1: Clinical Parameters collected for safety: Blood Flow	Clinical parameters: Blood flow recorded with L/min	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.
Phase 1: Clinical Parameters collected for safety: Mean arterial pressure (MAP)	Clinical parameters: MAP recorded with mmHg	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.
Phase 1: Clinical Parameters collected for safety: Mixed venous oxygen saturation (SvO2)	Clinical parameters: SvO2 recorded with percentage (%)	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.
Phase 1: Clinical Parameters collected for safety: Arterial oxygen saturation (SaO2)	Clinical parameters: SaO2 monitored with percentage	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.
Phase 1: Clinical Parameters collected for safety: Vacuum level	Clinical parameters: Vacuum level monitored with mmHg	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.
Phase 1: Vital sign collected for safety: body temperature	Vital signs: Body Temperature recorded with Celsius degrees (T°)	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).
Phase 1: Vital sign collected for safety: Heart Rate	Vital signs: Heart Rate recorded with beats/min	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).
Phase 1: Vital Sign collected for safety: Blood Flow	Vital Sign: Blood flow recorded with L/min	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).
Phase 1: Vital sign collected for safety: Diastolic pressure	Vital signs: Diastolic pressure recorded with mmHg	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).
Phase 1: Vital sign collected for safety: Sistolic pressure	Vital signs: Sistolic pressure recorded with mmHg	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).
Phase 1: Vital sign collected for safety: SpO2	Vital signs: SpO2 recorded with percentage (%)	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).
Phase 1: Device deficiencies/incidents collected for safety	Device deficiencies/incidents: recorded with number of Device Deficiencies or Incidents	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.
Phase 1: Concomitant medications collected for safety	Concomitant medications: Medications administered (dosage) during the study period.	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).
Phase 1: Drainage pressure collected for safety	Drainage pressure: venous pressure compared to blood flow recorded with mmHg	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.
Phase 1: Reinfusion pressure collected for safety	Reinfusion pressure: arterial pressure compared to blood flow recorded with mmHg	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.
Phase 1: Adequacy of tissue perfusion collected for safety	Adequacy of tissue perfusion recorded with levels of blood lactate	At Visit 1 Day 1 (Day of surgery): (pre) weaning/ decannulation
Phase 1: Patient's metabolic condition collected for safety: indexed oxygen delivery (DO2i )	Patient's metabolic condition DO2i recorded with ml/min/m2	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.
Phase 1: Patient's metabolic condition collected for safety: oxygen consuption (VO2)	Patient's metabolic condition VO2 recorded with ml/min	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.
Phase 1: Patient's metabolic condition collected for safety: oxygen extraction (O2ER)	Patient's metabolic condition O2ER recorded with percentage (%)	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.
Phase 1: Patient's metabolic condition collected for safety: venous oxygen saturation (SvO2)	Patient's metabolic condition SvO2 recorded with percentage (%)	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.
Phase 1: Patient's metabolic condition coillected for safety: arterial oxygen saturation (SaO2)	Patient's metabolic condition SaO2 recorded with percentage (%)	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.
Phase 1: Drainage efficacy of the venous cannula collected for safety	Drainage efficacy of the venous cannula recorded with levels of bilirubin	At Visit 0 (from day -3 to day -1 of surgical procedure) and Visit 2 (24 hours post-surgical procedure)
Phase 1: Drainage efficacy of the venous cannula collected for safety	Drainage efficacy of the venous cannula recorded with levels of creatinine	At Visit 0 (from day -3 to day -1 of surgical procedure) and Visit 2 (24 hours post-surgical procedure)
Phase 1: Drainage efficacy of the venous cannula collected for safety	Drainage efficacy of the venous cannula recorded with levels of transaminases	At Visit 0 (from day -3 to day -1 of surgical procedure) and Visit 2 (24 hours post-surgical procedure)
Phase 1: Duration of CPB procedure and clamping collected for safety	Duration of CPB procedure and clamping recorded with Time (minutes)	At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation.
Phase 1: (de)cannulation difficulty collected for safety	(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.	At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation
Phase 1: Integrity of arterial and venous cannula at decannulation collected for safety	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.	At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation
Phase 1: Presence of clots or thrombi in arterial and venous cannula at decannulation collected for safety	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.	At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation
Phase 1: Hospitalization stay collected for safety	The number of hospitalization days will be recorded up to patient discharge.	At Visit 3: Pre-discharge (within 6-7 days post-surgical procedure)
Phase 2: Drainage pressure (Pdrain) collected for non-inferiority with control group	Drainage pressure (Pdrain) recorded with mmHg. Results compared with control Venous Cannula.	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.
Phase 2: Reinfusion pressure (Pout) collected for non-inferiority with control group	Reinfusion pressure recorded with mmHg. Results compared with control Arterial Cannula.	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.
Phase 2: Adequacy of tissue perfusion collected for non-inferiority with control group	Adequacy of tissue perfusion recorded with levels of blood lactate. Results compared with control group	At Visit 1. Day 1 (Day of surgery): (pre) weaning/decannulation.
Phase 2: Patient's metabolic condition collected for non-inferiority with control group: indexed oxygen delivery (DO2i)	Patient's metabolic condition DO2i recorded with ml/min/m2. Results compared with control group.	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.
Phase 2: Patient's metabolic condition collected for non-inferiority with control group: oxygen consumption (VO2)	Patient's metabolic condition VO2 recorded with ml/min. Results compared with control group.	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.
Phase 2: Patient's metabolic condition collected for non-inferiority with control group: oxygen extraction (O2ER)	Patient's metabolic condition O2ER recorded with percentage (%). Results compared with control group.	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.
Phase 2: Patient's metabolic condition collected for non-inferiority with control group: venous oxygen saturation (SVO2)	Patient's metabolic condition SVO2 recorded with percentage (%). Results compared with control group.	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.
Phase 2: Patient's metabolic condition collected for non-inferiority with control group: arterial oxygen ssaturation (SaO2)	Patient's metabolic condition SaO2 recorded with percentage (%). Results compared with control group.	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.
Phase 2: Drainage efficacy of the venous cannula collected for non-inferiority with control group	Drainage efficacy of the venous cannula recorded with levels of bilirubin. Results compared with control group.	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).
Phase 2: Drainage efficacy of the venous cannula collected for non-inferiority with control group	Drainage efficacy of the venous cannula recorded with levels of creatinine. Results compared with control group.	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).
Phase 2: Drainage efficacy of the venous cannula collected for non-inferiority with control group	Drainage efficacy of the venous cannula recorded with levels of transaminases. Results compared with control group.	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).
Phase 2: Duration of CPB procedure and clamping time collected for non-inferiority with control group	Duration of CPB procedure and clamping time recorded with Time (minutes). Results compared with control group.	At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.
Phase 2: (de)cannulation difficulty collected for non-inferiority with control group	(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.	At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.
Phase 2: Integrity of arterial and venous cannula at decannulation collected for non-inferiority with control group	Integrity of arterial and venous cannula at decannulation recorded with YES or NO.	At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.
Phase 2: Presence of clots or thrombi in arterial and venous cannula at decannulation collected for non-inferiority with control group	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.	At Visit 1. Day 1 (Day of Surgery): (pre) weaning/decannulation.
Phase 2: Hospitalization stay collected for non-inferiority with control group	Hospitalization stay recorded with number of hospitalization days. Results compared with control group	At Visit 3 (End of Study). Pre-discharge (6-7 days post-surgical procedure).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pH	Clinical parameters monitored with pH value	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pCO2	Clinical parameters: pCO2 recorded with mmHg	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: pO2	Clinical parameters: pO2 recorded with mmHg	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Bloof flow	Clinical parameters: Blood flow recorded with L/min	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Mean arterial Pressure (MAP)	Clinical parameters: MAP recorded with mmHg	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Mixed venous oxygen saturation (SvO2)	Clinical parameters: SvO2 recorded with percentage (%)	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Arterial oxygen saturation (SaO2)	Clinical parameters: SaO2 monitored with percentage (%)	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of clinical parameters: Vaccum Level	Clinical parameters: Vacuum level monitored with mmHg	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: Body temperature	Description: Vital signs: Body Temperature recorded with Celsius degree (T°)	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).
Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: Heart Rate	Vital signs: Heart Rate recorded with beats/min	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).
Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: Blood flow	Vital Sign: Blood flow recorded with L/min	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).
Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: diastolic pressure	Vital signs: Diastolic pressure recorded with mmHg	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).
Safety Endpoint during Phase 2 (Pivotal): Monitoring of vital sign: sistolic pressure	Vital signs: Sistolic pressure recorded with mmHg	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).
Safety Endpoint during Phase 2 (Pivotal). Monitoring of vital sign: SpO2	Vital signs: SpO2 recorded with percentage (%)	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).
Safety Endpoint during Phase 2 (Pivotal): Monitoring of Device deficiencies/incidents	Device deficiencies/incidents recorded with number of Device Deficiencies or Incidents	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.
Safety Endpoint during Phase 2 (Pivotal): Monitoring of adverse events, and serious adverse events unrelated to study device	Number and type of adverse events, and serious adverse events unrelated to study device over the duration of the investigation.	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)
Safety Endpoint during Phase 2 (Pivotal): Monitoring of concomitant medications	Concomitant medications: Medications administered (dosage) during the study period.	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).

Collaborators and Investigators

• Sponsor: Eurosets S.r.l.

Publications and helpful links

General Publications

• Authors/Task Force Members; Kunst G, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Puis L, Wahba A; EACTS/EACTA/EBCP Committee Reviewers; Alston P, Fitzgerald D, Nikolic A, Onorati F, Rasmussen BS, Svenmarker S. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Br J Anaesth. 2019 Dec;123(6):713-757. doi: 10.1016/j.bja.2019.09.012. Epub 2019 Oct 2. No abstract available.
• Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/
• von Segesser LK, Ferrari E, Delay D, Maunz O, Horisberger J, Tozzi P. Routine use of self-expanding venous cannulas for cardiopulmonary bypass: benefits and pitfalls in 100 consecutive cases. Eur J Cardiothorac Surg. 2008 Sep;34(3):635-40. doi: 10.1016/j.ejcts.2008.05.037. Epub 2008 Jul 16.
• Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
• Lamelas J, Aberle C, Macias AE, Alnajar A. Cannulation Strategies for Minimally Invasive Cardiac Surgery. Innovations (Phila). 2020 May/Jun;15(3):261-269. doi: 10.1177/1556984520911917. Epub 2020 May 21.
• Narasaki S, Miyoshi H, Nakamura R, Sumii A, Watanabe T, Otsuki S, Tsutsumi YM. Venous cannula occlusion during cardiopulmonary bypass recognized by ultrasonography of the internal jugular vein. JA Clin Rep. 2022 Apr 12;8(1):29. doi: 10.1186/s40981-022-00519-2.
• Wahba A, Milojevic M, Boer C, De Somer FMJJ, Gudbjartsson T, van den Goor J, Jones TJ, Lomivorotov V, Merkle F, Ranucci M, Kunst G, Puis L; EACTS/EACTA/EBCP Committee Reviewers. 2019 EACTS/EACTA/EBCP guidelines on cardiopulmonary bypass in adult cardiac surgery. Eur J Cardiothorac Surg. 2020 Feb 1;57(2):210-251. doi: 10.1093/ejcts/ezz267. No abstract available.

Helpful Links

• [Yichao et al., 2006] Yichao Teng, HaiShu Ding, Qingcheng Gong, Zaishen Jia, Lan Huang, "Monitoring cerebral oxygen saturation during cardiopulmonary bypass using near-infrared spectroscopy: the relationships with body temperature and perfusion rate," J.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: November 20, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Cardiopulmonary Bypass; Medical Device; NIRS; Device Safety; Extracorporeal Circulation; Aortic Valve Surgery; CVP; Device Performance; Monocentric Study; Venous Cannula; Serious Adverse Events (SAE); Arterial Cannula; Coronary Surgery; Two Phases clinical investigation; Two Phases Study; Venous Cannula Drainage Pressure; Arterial Cannula Reinfusion Pressure
• Other Study ID Numbers: DE-62-22; CIV-IT-25-03-051856 (Other Identifier: Eudamed)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No