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

NCT06521164 | Not Yet Recruiting DMC

• 1 other identifier: HX-2024-0047
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Surgical Blood Loss; Surgical Complication

Keywords

cardiac surgery; therapeutic irrigation; postoperative bleeding; chest tubes; Haermonics Pure System

Outcome Measures

Primary Outcomes (3)

• 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, questions will be asked about the common use of the Hearmonics Pure system using a 0-10 Numeric Rating Scale.

  for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.

• 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, questions will be asked about the use of the Hearmonics Pure system in comparison with standard practice, with option 1 Hearmonics Pure system being better, with option 2 no difference, with option 3 standard of care being better.

  for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.

• 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, 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.

  for all users at the end of the study, after enrollment of 65 patients, after approximately 5 months after the start of the study.

Secondary Outcomes (6)

• Safety: Rate of device-related events up to discharge

  From enrollment up to discharge or up to 2 weeks after surgery, whichever came first

• 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.

• Safety: Rate of SAEs up to discharge

  From enrollment up to discharge or up to 2 weeks after surgery, whichever came first

• Efficacy: Drain fluid output 8 hours after start treatment (with sternum closed).

  start treatment (flushing) up to 8 hours after start treatment (flushing).

• 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

Study Arms (1)

study subjects

OTHER

1-arm study

Device: Haermonics Pure system

Interventions

Haermonics Pure system DEVICE

pericardial flushing with Haermonics Pure system

study subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Haermonics BV: lead
• Avania: collaborator

MeSH Terms

Conditions

Blood Loss, Surgical; Postoperative Hemorrhage

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications; Postoperative Complications

Central Study Contacts

Lian van Lippen

CONTACT

0031-625572304; vanlippen@haermonics.com

Stuart Head

CONTACT

0031-645306042; head@haermonics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 25, 2024
• Study Start: October 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share