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.
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
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
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.
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.
Anthea Hospital GVM Care & Research
Bari, BA, Italy
RECRUITINGPhase 1: Safety of Eurosets Arterial and Venous Cannulas
Number and type of adverse events over the duration of the investigation.
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)
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 frame: 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 frame: Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.
Phase 1: Clinical Parameters collected for safety: pH
Clinical parameters monitored with pH value
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.
Phase 1: Clinical Parameters collected for safety: pCO2
Clinical parameters: pCO2 recorded with mmHg
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.
Phase 1: Clinical Parameters collected for safety: pO2
Clinical parameters: pO2 recorded with mmHg
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.
Phase 1: Clinical Parameters collected for safety: Blood Flow
Clinical parameters: Blood flow recorded with L/min
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.
Phase 1: Clinical Parameters collected for safety: Mean arterial pressure (MAP)
Clinical parameters: MAP recorded with mmHg
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.
Phase 1: Clinical Parameters collected for safety: Mixed venous oxygen saturation (SvO2)
Clinical parameters: SvO2 recorded with percentage (%)
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.
Phase 1: Clinical Parameters collected for safety: Arterial oxygen saturation (SaO2)
Clinical parameters: SaO2 monitored with percentage
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.
Phase 1: Clinical Parameters collected for safety: Vacuum level
Clinical parameters: Vacuum level monitored with mmHg
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.
Phase 1: Vital sign collected for safety: body temperature
Vital signs: Body Temperature recorded with Celsius degrees (T°)
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).
Phase 1: Vital sign collected for safety: Heart Rate
Vital signs: Heart Rate recorded with beats/min
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).
Phase 1: Vital Sign collected for safety: Blood Flow
Vital Sign: Blood flow recorded with L/min
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).
Phase 1: Vital sign collected for safety: Diastolic pressure
Vital signs: Diastolic pressure recorded with mmHg
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).
Phase 1: Vital sign collected for safety: Sistolic pressure
Vital signs: Sistolic pressure recorded with mmHg
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).
Phase 1: Vital sign collected for safety: SpO2
Vital signs: SpO2 recorded with percentage (%)
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).
Phase 1: Device deficiencies/incidents collected for safety
Device deficiencies/incidents: recorded with number of Device Deficiencies or 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.
Phase 1: Concomitant medications collected for safety
Concomitant medications: Medications administered (dosage) during the study period.
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).
Phase 1: Drainage pressure collected for safety
Drainage pressure: venous pressure compared to blood flow recorded with mmHg
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.
Phase 1: Reinfusion pressure collected for safety
Reinfusion pressure: arterial pressure compared to blood flow recorded with mmHg
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.
Phase 1: Adequacy of tissue perfusion collected for safety
Adequacy of tissue perfusion recorded with levels of blood lactate
Time frame: 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
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.
Phase 1: Patient's metabolic condition collected for safety: oxygen consuption (VO2)
Patient's metabolic condition VO2 recorded with ml/min
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.
Phase 1: Patient's metabolic condition collected for safety: oxygen extraction (O2ER)
Patient's metabolic condition O2ER recorded with percentage (%)
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.
Phase 1: Patient's metabolic condition collected for safety: venous oxygen saturation (SvO2)
Patient's metabolic condition SvO2 recorded with percentage (%)
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.
Phase 1: Patient's metabolic condition coillected for safety: arterial oxygen saturation (SaO2)
Patient's metabolic condition SaO2 recorded with percentage (%)
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.
Phase 1: Drainage efficacy of the venous cannula collected for safety
Drainage efficacy of the venous cannula recorded with levels of bilirubin
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
Phase 2: Reinfusion pressure (Pout) collected for non-inferiority with control group
Reinfusion pressure recorded with mmHg. Results compared with control Arterial Cannula.
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.
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
Time frame: 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At Visit 3 (End of Study). Pre-discharge (6-7 days post-surgical procedure).
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