Status:
NOT_YET_RECRUITING
Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery
Lead Sponsor:
Haermonics BV
Collaborating Sponsors:
Avania
Conditions:
Surgical Blood Loss
Surgical Complication
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
This is a prospective, single-arm, single-center clinical investigation of adult patients undergoing cardiac surgery. Safety and efficacy of CPPF, with and without the device, has been established in ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity
- Participation in any study involving an investigational drug or device
- Patient is pregnant or nursing
- Inability to understand study information
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06521164
Start Date
October 1 2025
End Date
May 1 2026
Last Update
March 14 2025
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