New Treatment of Cardiac Device Infections; Immediate Reimplantation After Removal of Infected System
Recruiting
Phase 3
Interventional Study
Endocarditis, Bacterial
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 110
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 176 (estimated)
- Sponsor
- Rigshospitalet, Denmark · Other
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About This Trial
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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Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Culture positive or negative infection of a CIED acording to PI
* Indication for removal of device
* Clinical indication of device removal of existing device (concurrent left-sided IE is not a contraindication).
* Indication for reimplantation of new device
* A minimum of 3 da…
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