Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaermonics BV
About this trial
The goal of this clinical trial is to evaluate the usability of the Haermonics Pure system in patients undergoing a cardiac surgery procedure with the use of cardiopulmonary bypass.
All measurements and interventions are standard of care, except pericardial flushing with the Haermonics Pure system.
Eligibility criteria
Qualifiers
Adult patients (≥18yrs and weight ≥40kg) undergoing cardiothoracic surgery (CABG and/or valve surgery, elective aortic surgery, Bentall procedure, ascending aorto/aortic arch replacement) with the use of cardiopulmonary bypass
Patient has been informed of the nature of the clinical investigation and is willing and able to give written informed consent for investigation participation
Disqualifiers
Euroscore II > 20%
Emergent procedures
Complication during surgery which is life threatening and/or requires another surgical intervention
Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
Trial design
Treatments tested in this trial
- Haermonics Pure system
Treatment groups
65 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Haermonics BV
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov