Cardiac Implantable Electronic Device Infection Clinical Trial
Official title:
Centurion and Citadel Studies of TYRX™ Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following CIED Replacement With a CRT or ICD
The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device; either a cardiac resynchronization therapy device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial Envelope (formerly known as "AIGISRx"), to the incidence, after replacement with an ICD or CRT and no TYRX.
Cardiac implantable electronic device (CIED) infection is associated with significant
morbidity and expense. The frequency of CIED infection is increasing faster than the
frequency of CIED implants, suggesting more effective prophylactic strategies are needed.
The TYRX Anti-Bacterial Envelope is an FDA-cleared polypropylene mesh that is intended to
securely hold a pacemaker pulse generator or defibrillator (ICD) in order to create a stable
environment when implanted in the body. It contains the antimicrobial agents, rifampin and
minocycline, which have been shown to reduce infection in an in vivo model of bacterial
contamination following surgical implant of the generator or defibrillator.
This is a prospective, observational, multicenter registry of subjects undergoing CIED
replacement with an ICD or CRT and TYRX, with or without lead revision/addition. The
registry subjects will be compared to a published historical control group undergoing CIED
replacement with an ICD or CRT and no TYRX , with or without lead revision/addition. The CRT
registry subjects will also be compared to a case-matched retrospective control group
undergoing CIED replacement with a CRT and no TYRX , with or without lead revision/addition.
The primary study endpoints are major CIED infection and CIED mechanical complication during
the 12 months following CIED replacement with an ICD or CRT.
Originally executed as two separate studies (Citadel - ICDs) and (Centurion - CRTs), a
protocol amendment was executed in 2012 due to slow enrollment, combining the databases for
analysis of results.
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Observational Model: Case Control, Time Perspective: Prospective
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