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

NCT ID: NCT06521164

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-05-31

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.

Conditions

Surgical Blood Loss; Surgical Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

study subjects

1-arm study

Group Type: OTHER

Haermonics Pure system

Intervention Type: DEVICE

pericardial flushing with Haermonics Pure system

Interventions

Haermonics Pure system

pericardial flushing with Haermonics Pure system

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Avania

INDUSTRY

Sponsor Role: collaborator

Haermonics BV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Lian van Lippen

Role: CONTACT

vanlippen@haermonics.com

0031-625572304

Stuart Head

Role: CONTACT

head@haermonics.com

0031-645306042

Other Identifiers

HX-2024-0047

Identifier Type: -

Identifier Source: org_study_id