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AIGISRx Envelope for Prevention of Infection Following Replacement With a Cardiac Resynchronization Therapy Device (CRT) (CENTURION)

This study has suspended participant recruitment.
(Interim Data Analysis Complete, Safety Data Continues)
Sponsor:
Information provided by (Responsible Party):
TYRX, Inc.
ClinicalTrials.gov Identifier:
NCT01043705
First received: January 5, 2010
Last updated: May 20, 2013
Last verified: May 2013
History of Changes
  Purpose

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.


Condition
Cardiac Rhythm Management Device Infection

Study Type: Observational
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 a Cardiac Resynchronization Therapy Device (CRT)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Further study details as provided by TYRX, Inc.:

Primary Outcome Measures:
  • Major CRMD Infection [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CRMD Mechanical Complication [ Time Frame: 3, 6, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: January 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
CRMD replacement with CRT and AIGISRx
Patients who have undergone CRMD replacement with a CRT and the AIGISRx Anti-bacterial envelope, with or without lead revision (Prospective Arm)
CRMD replacement with CRT and no AIGISRx
Patients who have undergone CRMD replacement with a CRT and no AIGISRx Anti-bacterial envelope, with or without lead revision/addition(Retrospective Case-Control Arm)

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01043705

  Show 50 Study Locations
Sponsors and Collaborators
TYRX, Inc.
Investigators
Study Director: Daniel J. Lerner, MD TYRX, Inc.
  More Information

No publications provided by TYRX, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: TYRX, Inc.
ClinicalTrials.gov Identifier: NCT01043705     History of Changes
Other Study ID Numbers: CP-2009-2
Study First Received: January 5, 2010
Last Updated: May 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by TYRX, Inc.:
Pacemaker infection
Defibrillator infection
ICD infection
CRT infection
 Cardiovascular implantable electronic device infection
Infection
Pacemaker, Artificial
Defibrillators

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013