Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06250985
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-01
Brief Title:
New Treatment of Cardiac Device Infections Immediate Reimplantation After Removal of Infected System
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
New Treatment of Cardiovascular Implantable Electronic Device CIED Infections Immediate Reimplantation After Removal of Infected System
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POET-PPM
Brief Summary:
The goal of this randomized clinical trials is to ascertain the safety and efficacy of immediate reimplantation of cardiac electronic implantable devices in patients with endocarditis and device-infections compared to standard care ie reimplantation at a later procedure date
The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of
Death
Symptomatic embolism systemic arterial embolism or pulmonary embolism
Bacteremia og pocket-infection
Removal of a CIED due to new infection
The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of
Death
Symptomatic embolism systemic arterial embolism or pulmonary embolism
Bacteremia og pocket-infection
Removal of a CIED due to new infection
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None