View Clinical Trial (Medical Research Study)
AIGISRx Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following Cardiac Rhythm Management Device Replacement With an Implantable Cardioverter-Defibrillator (ICD)
| City: |
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Decatur |
| State: |
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Alabama |
| Zip Code: |
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35601 |
| Conditions: |
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Implantable Cardioverter-Defibrillator Infection |
| Purpose: |
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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.
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| Study Summary: |
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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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| Criteria: |
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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
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| NCT ID: |
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NCT01043861 |
| Primary Contact: |
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Study Director
Daniel J. Lerner, MD
TYRX, Inc.
Steve A. Sisk, MsSc. Pharm
Phone: 609-894-2289
Email: ssisk@tyrx.com
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| Backup Contact: |
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Email: rhamlin@tyrx.com
Robert J Hamlin, BSc
Phone: 732-964-1123
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| Location Contact: |
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Decatur, Alabama 35601
United States
Tracy Neal, MD
Phone: 256-341-2890
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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