Usability of Pericardial Flushing with the Haermonics Pure System After Cardiac Surgery

Launched by HAERMONICS BV · Jul 22, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new system called the Haermonics Pure, which is used to help clean the area around the heart during certain types of heart surgeries. The main goal is to see how well this system works in patients who are having surgeries like bypass surgery or valve repair, where a heart-lung machine is used to take over the job of pumping blood. While most of the care in this study will be standard practice, the trial will specifically focus on how effective the Haermonics Pure system is for flushing the heart area.

To be eligible for this study, participants must be adults aged 18 or older, weigh at least 40 kilograms, and be scheduled for certain heart surgeries that use the heart-lung machine. However, people with serious health risks, emergency surgeries, or certain other complications won't be included. If someone decides to participate, they will need to give their written consent and can expect to receive standard care along with the special procedure using the Haermonics Pure system. This study is not yet recruiting participants, but it aims to gather important information that could improve heart surgery outcomes in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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 Criteria:
• • 1. Euroscore II \> 20%
• • 2. Emergent procedures
• • 3. Complication during surgery which is life threatening and/or requires another surgical intervention
• • 4. Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)
• • 5. Thoraco-abdominal surgery, or intraoperative injury to the diaphragm leading to an open connection between the thoracic and abdominal cavity
• • 6. Participation in any study involving an investigational drug or device
• • 7. Patient is pregnant or nursing
• • 8. Inability to understand study information