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AIGISRx Envelope for Prevention of Infection Following Replacement With a Cardiac Resynchronization Therapy Device (CRT)

2014-07-23 21:11:12 | BioPortfolio

Summary

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 a cardiac resynchronization therapy device (CRT) and AIGISRx Anti-Bacterial Envelope, to the incidence after replacement with a CRT and no AIGISRx.

Description

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 a CRT and AIGISRx, with or without lead revision/addition. The registry subjects will be compared to a case-matched retrospective control group undergoing CRMD replacement with a CRT 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 CRT.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Conditions

Cardiac Rhythm Management Device Infection

Location

Princeton Medical Center
Birmingham
Alabama
United States
35211

Status

Recruiting

Source

TYRX, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:12-0400

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