Cardiac SurgeryNCT07354841
Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
A study testing Eurosets Venous and Arterial Cannula in people with Cardiac Surgery and Heart Surgery, run by Eurosets S.r.l. at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass
- What is being tested?
- Eurosets Venous and Arterial Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Emergency cases;
- Re-do cardiac surgery procedure;
- Diabetes mellitus;
- Hematologic diseases or history of thrombophilia;
- Pregnancy or breastfeeding;
- Concomitant major cardiac procedures;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Anthea Hospital GVM Care & Research
Bari, BA, 70124
About this study
Official 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
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.
Read the 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).
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery, Aortic Valve Surgery, Cannulation
- Being tested
- Eurosets Venous and Arterial Cannula, Control Arterial and Venous Cannulas
- Keywords
- Arterial Cannula, Venous Cannula, Extracorporeal Circulation, Cardiopulmonary Bypass, Cardiac Surgery, Medical Device, Device Safety, Device Performance, Aortic Valve Surgery, Coronary Surgery, Two Phases clinical investigation, Monocentric Study, Two Phases Study, Serious Adverse Events (SAE), CVP, NIRS, Venous Cannula Drainage Pressure, Arterial Cannula Reinfusion Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eurosets Venous and Arterial CannulaDevice
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 CannulasDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Eurosets Arterial and Venous Cannula | Experimental | 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. Receives: Device: Eurosets Venous and Arterial Cannula |
| Control Arterial and Venous Cannula | Active comparator | Phase 2: Participants will undergo cardiopulmonary bypass using commercially available arterial and venous cannulas currently used in standard clinical practice. Receives: Device: Control Arterial and Venous Cannulas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety of Eurosets Arterial and Venous Cannulas
Number and type of adverse events over the duration of the investigation.
Measured: 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.
Measured: 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.
Measured: Time points during CPB: 1st: pre-clamping/CPB initiation (full flow), 2nd: 10 minutes post-clamping, 3rd: 30 minutes post-clamping.
Secondary outcomes (48)
Phase 1: Clinical Parameters collected for safety: pH
Clinical parameters monitored with pH value
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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
Measured: 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
Measured: 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°)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 (%)
Measured: 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 (%)
Measured: 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 (%)
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: At Visit 3 (End of Study). Pre-discharge (6-7 days post-surgical procedure).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start21 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1: Pilot, not Randomized, Monocentric one arm Clinical Investigation with pre-market medical device Phase 2: Pivotal, Randomized, Non-inferiority, Monocentric, two arm Clinical Investigation with pre-market medical device
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eurosets S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354841
- Sponsor's protocol ID
- DE-62-22
- Other IDs
- CIV-IT-25-03-051856
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/
PubMed 29489210von 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.
PubMed 18635371Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
PubMed 28970635Authors/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.
PubMed 31585674Lamelas 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.
PubMed 32437215Narasaki 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.
PubMed 35412158Wahba 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.
PubMed 31576396
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07354841
- Acronym / sponsor ID
- DE-62-22
- Conditions
- Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery, Aortic Valve Surgery, Cannulation
- Keywords
- Arterial Cannula, Venous Cannula, Extracorporeal Circulation, Cardiopulmonary Bypass, Cardiac Surgery, Medical Device, Device Safety, Device Performance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Eurosets S.r.l.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1: Pilot, not Randomized, Monocentric one arm Clinical Investigation with pre-market medical device Phase 2: Pivotal, Randomized, Non-inferiority, Monocentric, two arm Clinical Investigation with pre-market medical device
| Arm | Type | Receives |
|---|---|---|
| Eurosets Arterial and Venous Cannula | Experimental | Device: Eurosets Venous and Arterial CannulaPhase 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. |
| Control Arterial and Venous Cannula | Active comparator | Device: Control Arterial and Venous CannulasPhase 2: Participants will undergo cardiopulmonary bypass using commercially available arterial and venous cannulas currently used in standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (20 listed)
- Emergency cases;
- Re-do cardiac surgery procedure;
- Diabetes mellitus;
- Hematologic diseases or history of thrombophilia;
- Pregnancy or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eurosets Venous and Arterial CannulaPhase 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. | Device | Eurosets Arterial and Venous Cannula |
| Control Arterial and Venous CannulasPhase 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. | Device | Control Arterial and Venous Cannula |
Primary outcome
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.
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.
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.
48 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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).
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).
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.
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).
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.
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.
Phase 1: Adequacy of tissue perfusion collected for safety
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 )
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)
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)
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)
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)
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
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
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
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
Time frame: At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation.
Phase 1: (de)cannulation difficulty collected for safety
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
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
Time frame: At Visit 1 Day 1 (day of surgery): (pre) weaning/ decannulation
Phase 1: Hospitalization stay collected for safety
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
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
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
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)
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)
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)
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)
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 29489210Ismail A, Semien G, Sharma S, Collier SA, Miskolczi SY. Cardiopulmonary Bypass. 2024 Aug 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK482190/
- Results publication: PubMed 18635371von 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.
- Results publication: PubMed 28970635Sarkar M, Prabhu V. Basics of cardiopulmonary bypass. Indian J Anaesth. 2017 Sep;61(9):760-767. doi: 10.4103/ija.IJA_379_17.
- Results publication: PubMed 31585674Authors/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.
- Results publication: PubMed 32437215Lamelas 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.
- Results publication: PubMed 35412158Narasaki 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.
- Results publication: PubMed 31576396Wahba 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.
- \[Yichao et al., 2006\] 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.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eurosets Venous and Arterial Cannula in people with Cardiac Surgery and Heart Surgery, run by Eurosets S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Giuseppe Nasso (+39 080 5644111, gnasso@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07354841, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.