Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

Recruiting N/A Interventional Study
Cardiac Surgery Heart Surgery Cardiopulmonary Bypass Coronary Surgery Aortic Valve Surgery Cannulation Venous Cannulation Arterial Cannulation Coronary Surgery With Cardiopulmonary Bypass
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Other
Participants needed
80 (estimated)
Sponsor
Eurosets S.r.l. · Industry
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About This Trial
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 obta…
Trial Locations
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Eligibility Criteria
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 sc…
Contacts

Prof. Giuseppe Nasso

+39 080 5644111

gnasso@libero.it

CONTACT