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.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 80 (estimated)
- Sponsor
- Eurosets S.r.l. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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