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

Not Applicable

Not yet recruiting

• Conditions: Surgical Blood Loss; Surgical Complication
• Interventions: Device: Haermonics Pure system

• Registration Number: NCT06521164
• Lead Sponsor: Haermonics BV

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 and interventions are standard of care, except pericardial flushing with the Haermonics Pure system.

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 comparison with standard drainage. Therefore, this study is designed primarily to establish the usability of the device and its accessories, not requiring randomization against a control group.

Because the Haermonics Pure system and its accessories are used directly after surgery for several hours up to several days until drain removal before being discharged from the hospital, it is sufficient to follow patients until discharge from the cardiac surgery department. For patients with a prolonged hospitalization because of postoperative complications, it is considered sufficient to follow patients for 2 weeks after surgery because the impact of a pericardial flushing and postoperative drainage on outcomes is critical within the immediate postoperative period but limited beyond the time that the drains are removed. For device-related adverse events, follow-up will continue until the event is considered resolved or the patient is discharged.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-22
• Study First Posted: 2024-07-25
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-11
• Last Update Posted: 2025-03-14
• Study Start: 2025-10-01
• Primary Completion: 2026-05
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study subjects	Haermonics Pure system	1-arm study

Primary Outcome Measures

Name	Time	Method
Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.	for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.	For each user, questions will be asked about the common use of the Hearmonics Pure system using the System Usability Scale (SUS). It is comprised of 10 questions that should be answered on a 5-point Likert scale.

Secondary Outcome Measures

Name	Time	Method
Safety: Rate of device-related events up to discharge	From enrollment up to discharge or up to 2 weeks after surgery, whichever came first	Descriptive statistics
Usability to evaluate user satisfaction and functionality of all use aspects of the Haermonics Pure system within 65 patients by using a user questionnaire.	For each user at each step for each patient trough study completion, which is expected to be around 3 times a week during approximately 5 months.	Used by different user groups in different hospital settings when using the different components of the Haermonics Pure system for the different functionalities. User satisfaction is measured with a user questionaire, containing questions with a scale from 1-4, with 1: very unsatisfied, 2: unsatified; 3 satisfied; 4 very satisfied.
Safety: Rate of SAEs up to discharge	From enrollment up to discharge or up to 2 weeks after surgery, whichever came first	Relationship with the device will be determined for all SAEs. All events of reoperations, pericardiocetesis and pleurcentesis are considered to be SAEs.
Efficacy: Drain fluid output 8 hours after start treatment (with sternum closed).	start treatment (flushing) up to 8 hours after start treatment (flushing).	Total amount of fluid output, comparing this with the historical control established in the previous FLUID trial.
Technical Efficacy: Number of device deficiencies leading to permanently stopping the treatment for each patient, 65 patients in total	start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery	Device deficiencies will be recorded, including the description of the technical issue.
Efficacy: Occurance of drain occlusion	start treatment (flushing) up to removal of drains, which is typically 12-24 hours after surgery	Having to permanently stop flushing as a result of retained fluid and no chest tube output. Patients with chest tube output until flushing is terminated and without retention that is not produced after flushing is terminated will by default not have occluded drains. It will be collected how many times the infusion was paused and/ or stopped due to fluid retention for each patient.