Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06521164
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
Usability of Pericardial Flushing With the Haermonics Pure System After Cardiac Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Usability of Pericardial Flushing With the Haermonics Pure System After Cardiac Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
USEPURE
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None