NCT06521164

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Haermonics BV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Haermonics Pure system	pericardial flushing with Haermonics Pure system

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2024-07-25
• Last updated: 2025-03-14