Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07354841

Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

Led by Eurosets S.r.l. · Updated on 2026-01-21

80

Participants Needed

1

Research Sites

49 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Safety and Performance Evaluation of CPB Venous and Arterial Cannulas

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is able and willing to provide written informed consent.
  • Female and male patients aged 18 years or older.
  • Body weight between 60 and 120 kg.
  • Body surface area between 1.5 and 2.5 m2.
  • Patients scheduled for elective central cannulation for cardiopulmonary bypass during isolated coronary and/or aortic valve surgery.
Not Eligible

You will not qualify if you...

  • Emergency surgery cases.
  • Re-do cardiac surgery procedures.
  • Diabetes mellitus.
  • Hematologic diseases or history of thrombophilia.
  • Pregnancy or breastfeeding.
  • Concomitant major cardiac procedures.
  • Active malignant or metastatic cancer.
  • Presence of pneumothorax or pulmonary emphysema.
  • Significant central nervous system injury.
  • Current intracranial hemorrhage.
  • Immunosuppression.
  • Contraindication to therapeutic anticoagulation (e.g., heparin).
  • Anatomical or structural abnormalities that may interfere with study participation.
  • Abnormal or pathological cannulation site.
  • Uncontrolled active bleeding.
  • Awaiting transplantation.
  • Requiring preoperative extracorporeal membrane oxygenation.
  • Any severe condition or abnormal laboratory parameters interfering with study participation.
  • Participation in another interventional clinical study.
  • Unable to understand the study or unwilling/unable to attend the end of study visit.

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Anthea Hospital GVM Care & Research

Bari, BA, Italy, 70124

Actively Recruiting

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Research Team

P

Prof. Giuseppe Nasso

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

OTHER

Number of Arms

2

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