AIGISRx Envelope for Prevention of Infection Following Replacement With an Implantable Cardioverter-Defibrillator (ICD) (CITADEL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
TYRX, Inc.
ClinicalTrials.gov Identifier:
NCT01043861
First received: January 5, 2010
Last updated: July 26, 2013
Last verified: July 2013

January 5, 2010
July 26, 2013
January 2010
July 2013   (final data collection date for primary outcome measure)
Major CRMD Infection [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01043861 on ClinicalTrials.gov Archive Site
CRMD Mechanical Complication [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
AIGISRx Envelope for Prevention of Infection Following Replacement With an Implantable Cardioverter-Defibrillator (ICD)
AIGISRx Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following Cardiac Rhythm Management Device Replacement With an Implantable Cardioverter-Defibrillator (ICD)

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Implantable Cardioverter Defibrillator Infection
Not Provided
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
465
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01043861
CP-2009-1
Yes
TYRX, Inc.
TYRX, Inc.
Not Provided
Study Director: Daniel J. Lerner, MD TYRX, Inc.
TYRX, Inc.
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP