Safety and Performance Evaluation of CPB Venous and Arterial Cannulas
Recruiting now · Not applicable
Conditions studied: Cardiac Surgery, Heart Surgery, Cardiopulmonary Bypass, Coronary Surgery, Aortic Valve Surgery, Cannulation, Venous Cannulation, Arterial Cannulation, Coronary Surgery With Cardiopulmonary Bypass
In brief
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.
Key facts
- Study ID
- NCT07354841
- Run by
- Eurosets S.r.l.
- People needed
- 80
- Starts
- 2025-10-21
- Expected to finish
- 2026-09-30
- Last updated by the study team
- 2026-01-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- Emergency cases;
- Re-do cardiac surgery procedure;
- Diabetes mellitus;
- Hematologic diseases or history of thrombophilia;
- Pregnancy or breastfeeding;
- Concomitant major cardiac procedures;
- Active malignant/metastatic neoplasm of any type;
- Presence of pneumothorax and/or pulmonary emphysema;
- Significant central nervous system injury;
- Current intracranial hemorrhage;
- Immunosuppression;
- Contraindication for therapeutic anticoagulation (e.g., heparin);
- Anatomical and structural abnormalities which, in the opinion of the Investigator, may interfere with the participation to the study;
- Abnormal or pathological cannulation site;
- Uncontrolled active bleeding;
- Awaiting transplantation;
- Requiring preoperative extracorporeal membrane oxygenation;
- Presence of any relevant severe condition or clinically relevant abnormal laboratory parameters that in the opinion of the Investigator may interfere with the participation to the study.
- Patient is taking part in another interventional clinical study;
- Patient is not able to understand the nature of this study or is unwilling or unable to attend the EOS Visit.
Where it is running
- Anthea Hospital GVM Care & Research — Bari, BA, Italy (enrolling)
Full record on ClinicalTrials.gov
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