CompletedNot Applicable

Novel Venous Cannula Trial

Italy42 participantsStarted 2022-12-22

Plain-language summary

This is a prospective, open-label, single-arm, single-center clinical investigation designed to evaluate the safety and performance of a Novel Venous Cannula during on-pump cardiac surgery requiring transfemoral venous cannulation. The investigation aims to assess the pressure drop across the cannula during extracorporeal circulation and the incidence of serious adverse events associated with its use. A total of 42 participants will be enrolled.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Informed consent obtained * Hospitalised patients undergoing transfemoral venous cannulation for on pump cardiac surgery procedure Exclusion Criteria: * Active bleeding * Need of ECLS * Low platelet count (\<150,000) * Any clinical conditions that contra-indicate the anti-coagulation * Any clinical condition that, in the opinion of the investigator, may interfere with the procedure * Subjects participating in any other clinical trial or investigation with a medical device within 3 months before Assessment visit

What they're measuring

Effectiveness: the mean pressure drop (mm Hg) to maintain the desired flow rate (L/min) during the standard surgical procedure

Timeframe: During the surgical procedure (Day 0)

Safety: the number of SAE with the Novel Venous Cannula during the standard surgical procedure

Timeframe: From Day 0 (procedure day) to 7 days post-procedure

Trial details

NCT IDNCT07087639

SponsorEurosets S.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-05

View on ClinicalTrials.gov More Cardiac Surgery trials