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.

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.

Patients who have undergone CRMD replacement with an ICD, with or without an AIGISRx Anti-bacterial Envelope, at US medical centers.

Inclusion Criteria:

• Qualifying CRMD Implant procedure was replacement with a ICD and AIGISRx, with or without lead revision/addition
• Received a complete AIGISRx Anti-Bacterial Envelope Model# 3122 or #3133 according to the Instructions for Use (IFU)
• Clinically stable to tolerate procedure
• 18 years or older
• Able to return for follow-up care through the 12-month visit, or able to have referring physician provide follow-up data to study site by telephone

Exclusion Criteria:

• Unable/unwilling to provide informed consent
• Contraindication to receiving the AIGISRx device, in accordance with the package labeling
• Pregnant or was at risk for becoming pregnant in the 30 day period following the Qualifying CRMD Implant
• Current CRMD infection, or the indication for Qualifying CRMD Implant was replacement of CRMD that was explanted for infection
• Clinical diagnosis of an active infection at the time of CRMD implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection. (Note: asymptomatic bacteriuria without UTI is not an exclusion criterion)
• Generator replacement required planned lead extraction
• Participating in another clinical study evaluating a drug or device designed to reduce cardiovascular rhythm management device infections
• Life expectancy of less than 6 months
• Expected to receive a heart transplant within 6 months
• With the exception of the elderly in good mental health, all vulnerable subjects as defined by the FDA Office of Human Research Protection or local IRB will be excluded