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The purpose of this study is to compare the incidence of cardiac rhythm management device (CRMD) infection and CRMD mechanical complication after CRMD replacement with an Implantable Cardioverter-Defibrillator (ICD) and AIGISRx Anti-Bacterial Envelope, to the incidence after replacement with an ICD and no AIGISRx.
Cardiac rhythm management device (CRMD) infection is associated with significant morbidity and expense. The frequency of CRMD infection is increasing faster than the frequency of CRMD implants, suggesting more effective prophylactic strategies are needed.
The AIGISRx 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 CRMD replacement with an ICD and AIGISRx, with or without lead revision/addition. The registry subjects will be compared to a published historical control group undergoing CRMD replacement with an ICD and no AIGISRx, with or without lead revision/addition. The primary study endpoints are major CRMD infection and CRMD mechanical complication during the 12 months following CRMD replacement with a ICD.
Observational Model: Case Control, Time Perspective: Prospective
Implantable Cardioverter-Defibrillator Infection
Princeton Medical Center
Published on BioPortfolio: 2014-07-23T21:11:12-0400
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Types of artificial pacemakers with implantable leads to be placed at multiple intracardial sites. They are used to treat various cardiac conduction disturbances which interfere with the timing of contraction of the ventricles. They may or may not include defibrillating electrodes (IMPLANTABLE DEFIBRILLATORS) as well.
Implantable devices which continuously monitor the electrical activity of the heart and automatically detect and terminate ventricular tachycardia (TACHYCARDIA, VENTRICULAR) and VENTRICULAR FIBRILLATION. They consist of an impulse generator, batteries, and electrodes.
Surgically placed electric conductors through which ELECTRIC STIMULATION of nerve tissue is delivered.
Implantable fracture fixation devices attached to bone fragments with screws to bridge the fracture gap and shield the fracture site from stress as bone heals. (UMDNS, 1999)
Infection by a variety of fungi, usually through four possible mechanisms: superficial infection producing conjunctivitis, keratitis, or lacrimal obstruction; extension of infection from neighboring structures - skin, paranasal sinuses, nasopharynx; direct introduction during surgery or accidental penetrating trauma; or via the blood or lymphatic routes in patients with underlying mycoses.
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