| Conditions: |
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Cardiac Rhythm Management Device 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 a cardiac
resynchronization therapy device (CRT) and AIGISRx Anti-Bacterial Envelope, to the incidence
after replacement with a CRT 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 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.
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| Criteria: |
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Inclusion Criteria: - Prospective Arm
- Qualifying CRMD Implant procedure was replacement with a CRT 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: - Prospective Arm
- 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
Inclusion Criteria: - Case-matched retrospective Control Arm
- Qualifying CRMD Implant was replacement with a CRT and AIGISRx, with or without lead
revision/addition
- First un-enrolled patient meeting case-matching criteria in series of patients
implanted with a CRMD and no AIGISRx beginning 24 months prior to the date of first
AIGISRx implant at site. If no matching patients in this period, first un-enrolled
matching patient implanted with a CRMD and no AIGISRx beginning 24 months prior to
the first AIGISRx implant at site, searching in reverse chronological order
- Had at least one of following by date of enrollment into the study:
1. ≥ 12 months follow-up after Qualifying CRMD Implant
2. Subsequent CRMD Procedure that required opening the generator pocket or implant
incision ≤ 12 months after Qualifying CRMD Implant (e.g. battery change,
upgrade, lead revision, explant)
3. Death ≤ 12 months after Qualifying CRMD Implant
- Survived Qualifying CRMD Implant to discharge, died of a CRMD infection or Mechanical
Complication prior to hospital discharge, or died for any reason un-related to
Qualifying CRMD Implant prior to hospital discharge
- 18 years or older
Exclusion Criteria: - Case-matched retrospective Control Arm
- Contraindication to receiving the AIGISRx device, in accordance with the package
labeling
- Pregnant or became pregnant in the 30 day period following the Qualifying CRMD
Implant.
- 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 Qualifying 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)
- Lead extraction was performed at the Qualifying CRMD Implant
- Participated in another clinical study evaluating a drug or device intended to reduce
cardiovascular rhythm management device infections
- Received a heart transplant within 6 months of Qualifying CRMD Implant
- 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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NCT01043705 |
| Primary Contact: |
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Study Director
Daniel J. Lerner, MD
TYRX, Inc.
Steve A. Sisk, MsSc. Pharm
Phone: 732-964-1169
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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Hattiesburg, Mississippi 39401
United States
Eric W Enger, MD
Phone: 601-268-5800
Email: fraces.findley@hattiesburgclinic.com
Site Status: Recruiting |