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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, i.e. reimplantation at a later procedure date.
The primary outcome is the occurence of the composite primary endpoint within 6 months of randomization consisting of
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate reimplantation | Experimental | Reimplantation in same procedure as removal of device or shortly thereafter. |
|
| Standart care | Active Comparator | Reimplantation of device in a second procedure at a later date, after infection has been stabilized/cleared |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Timing of reimplantation | Other | Patients will be rendomized 1:1 by computer to recieve either standart care or intervention prior to removal of infected system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite primary outcome | Composite endpoint consisting of number of participants with one or more of the following events during follow-up: death, symptomatic embolism (systemic or pulmonary), bacteremia or pocket infection with same bacterial pathogen or removal of device due to new infection. | within 6 months of randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Henning Bundgaard, MD, DMSc | Contact | 35453534 | henning.bundgaard@regionh.dk | |
| Mia M Pries-Heje, MD, PhD | Contact | mia.marie.pries-heje.01@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Henning Henning | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D004697 | Endocarditis, Bacterial |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D053821 | Cardiovascular Infections |
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| D002318 | Cardiovascular Diseases |
| D004696 | Endocarditis |
| D006331 | Heart Diseases |