World-wide Randomization Antibiotic Envelope Infection Prevention Trial (WRAP-IT)
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- STATUS
- Recruiting
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- participants needed
- 80
Summary
This study is a single-blinded,randomized,prospective, multi-center clinical trial. The study will evaluate the ability of the TYRX absorable Antibacterial Envelope to reduce major cardiovascular implantable electronic device (CIED) infections. Patients undergoing CIED generator replacement, upgrade, revision or new biventricular defibrillator system will be randomized to receive the TYRX envelope or not to receive the TYRX envelope. A CIED is an implantable defibrillator or pacemaker.
Details
| Condition | pacemakers, defibrillators |
|---|---|
| Age | 1years - 100years |
| Clinical Study Identifier | TX1036 |
| Last Modified on | 19 February 2024 |
Eligibility
How to participate?
Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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