AIGISRx Envelope for Prevention of Infection Following Replacement With an Implantable Cardioverter-Defibrillator (ICD) (CITADEL)
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.
Implantable Cardioverter Defibrillator Infection
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||AIGISRx Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following Cardiac Rhythm Management Device Replacement With an Implantable Cardioverter-Defibrillator (ICD)|
- Major CRMD Infection [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
- CRMD Mechanical Complication [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
CRMD replacement with ICD and AIGISRx
Patients who have undergone CRMD replacement with an ICD and the AIGISRx Anti-bacterial envelope, with or without lead revision (Prospective Arm)
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.
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|Study Director:||Steve A Sisk, MSc Pharmacy||Medtronic/Tyrx, Inc.|