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TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD (Centurion)

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ClinicalTrials.gov Identifier: NCT01043705
Recruitment Status : Completed
First Posted : January 7, 2010
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
TYRX, Inc.

Tracking Information
First Submitted Date January 5, 2010
First Posted Date January 7, 2010
Results First Submitted Date October 13, 2015
Results First Posted Date December 24, 2015
Last Update Posted Date December 24, 2015
Study Start Date January 2010
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2015)
  • Major CIED Infection [ Time Frame: 12 months ]
    CIED Major Infections
  • CIED Mechanical Complication [ Time Frame: 12 months ]
    All mechanical Complications related to CIED Implant
Original Primary Outcome Measures
 (submitted: January 6, 2010)
Major CRMD Infection [ Time Frame: 3, 6, and 12 months ]
Change History Complete list of historical versions of study NCT01043705 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures
 (submitted: January 6, 2010)
CRMD Mechanical Complication [ Time Frame: 3, 6, and 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
Official Title Centurion and Citadel Studies of TYRX™ Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following CIED Replacement With a CRT or ICD
Brief Summary The purpose of this study is to compare the incidence of cardiac implantable electronic device (CIED) infection and CIED mechanical complication after CIED replacement with a high-power cardiac implantable electronic device; either a cardiac resynchronization therapy device (CRT), or an implantable cardioverter defibrilator (ICD) and TYRX Anti-Bacterial Envelope (formerly known as "AIGISRx"), to the incidence, after replacement with an ICD or CRT and no TYRX.
Detailed Description

Cardiac implantable electronic device (CIED) infection is associated with significant morbidity and expense. The frequency of CIED infection is increasing faster than the frequency of CIED implants, suggesting more effective prophylactic strategies are needed.

The TYRX 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 CIED replacement with an ICD or CRT and TYRX, with or without lead revision/addition. The registry subjects will be compared to a published historical control group undergoing CIED replacement with an ICD or CRT and no TYRX , with or without lead revision/addition. The CRT registry subjects will also be compared to a case-matched retrospective control group undergoing CIED replacement with a CRT and no TYRX , with or without lead revision/addition. The primary study endpoints are major CIED infection and CIED mechanical complication during the 12 months following CIED replacement with an ICD or CRT.

Originally executed as two separate studies (Citadel - ICDs) and (Centurion - CRTs), a protocol amendment was executed in 2012 due to slow enrollment, combining the databases for analysis of results.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients who have undergone CIED replacement with an ICD or CRT, with or without (CRT retrospective group only) an TYRX Anti-bacterial Envelope, at US medical centers.
Condition Cardiac Implantable Electronic Device Infection
Intervention Not Provided
Study Groups/Cohorts
  • CIED replacement with CRT and TYRX
    (Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
  • CIED replacement with ICD and TYRX
    (Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
  • CIED replacement with ICD or CRT and TYRX
    (Prospective Arm) Patients who have undergone CIED replacement with an ICD or CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
  • CIED replacement w/ CRT & no TYRX
    (Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
  • CIED replacement w/ CRT & TYRX vs. Case Match Arm
    Patients who have undergone CIED replacement with a CRT and TYRX Anti-bacterial envelope, with or without lead revision/addition. Cohort is TYRX Case, Matched to Retrospective Case-Control Arm)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 20, 2015)
1262
Original Estimated Enrollment
 (submitted: January 6, 2010)
4000
Actual Study Completion Date May 2015
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria: - Prospective Arms

  • Qualifying CIED Implant procedure was replacement with an ICD or CRT and TYRX, with or without lead revision/addition
  • Received a complete TYRX 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 TYRX device, in accordance with the package labeling
  • Pregnant or was at risk for becoming pregnant in the 30 day period following the Qualifying TYRX Implant
  • Current CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection
  • Clinical diagnosis of an active infection at the time of CIED implant, including pneumonia, urinary tract infection, endovascular, cellulitis, bacteremia, or other major systemic infection. (Note: asymptomatic bacteremia 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 CIED 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 CIED Implant was replacement with a CRT and TYRX, with or without lead revision/addition
  • First un-enrolled patient meeting case-matching criteria in series of patients implanted with a CIED and no TYRX beginning 24 months prior to the date of first TYRX implant at site. If no matching patients in this period, first un-enrolled matching patient implanted with a CIED and no TYRX beginning 24 months prior to the first TYRX 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 TYRX Implant
    2. Subsequent TYRX Procedure that required opening the generator pocket or implant incision ≤ 12 months after Qualifying TYRX Implant (e.g. battery change, upgrade, lead revision, explant)
    3. Death ≤ 12 months after Qualifying CIED Implant
  • Survived Qualifying CIED Implant to discharge, died of a CIED infection or Mechanical Complication prior to hospital discharge, or died for any reason un-related to Qualifying CIED Implant prior to hospital discharge
  • 18 years or older

Exclusion Criteria: - Case-matched retrospective Control Arm

  • Contraindication to receiving the TYRX device, in accordance with the package labeling
  • Pregnant or became pregnant in the 30 day period following the Qualifying TYRX Implant.
  • CIED infection, or the indication for Qualifying CIED Implant was replacement of CIED that was explanted for infection
  • Clinical diagnosis of an active infection at the time of Qualifying CIED 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 CIED Implant
  • Participated in another clinical study evaluating a drug or device intended to reduce CIED infections
  • Received a heart transplant within 6 months of Qualifying CIED 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01043705
Other Study ID Numbers CP-2009-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party TYRX, Inc.
Study Sponsor TYRX, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account TYRX, Inc.
Verification Date October 2015