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Cardiac Implantable Electronic Device InfectionCenturionNCT01043705

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

An observational study of Cardiac Implantable Electronic Device Infection, run by TYRX, Inc. at 52 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
How many people
1,262 participants
Where
52 sitesUnited States
Study dates
Jan 2010to May 2015
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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:
  • ≥ 12 months follow-up after Qualifying TYRX Implant
  • 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)
  • 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

Trial locations and contacts

52 sites in 1 country.

52 sites in 1 country

United States52 sites

  • Piedmont Medical Center

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Veteran's Administration Medical Center

    Atlanta, Georgia, 30345

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Johns Hopkins University Hospital

    Baltimore, Maryland, 21205

  • Gulfport Memorial Hospital

    Biloxi, Mississippi, 39532

  • Keesler Air Force Base Hospital

    Biloxi, Mississippi, 39534

  • Princeton Medical Center

    Birmingham, Alabama, 35211

  • Massachusetts General Hospital

    Boston, Massachusetts, 02144

  • Decatur General Hospital

    Decatur, Alabama, 35601

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Doylestown Hospital

    Doylestown, Pennsylvania, 18901

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Eliza Coffee Memorial Hospital

    Florence, Alabama, 35630

  • Riverview Regional Hospital

    Gadsden, Alabama, 35901

  • Stern Cardiovascular Foundation

    Germantown, Tennessee, 38138

  • St. Francis Hospital

    Hamilton, New Jersey, 08690

  • Pinnacle Health Harrisburg Hospital

    Harrisburg, Pennsylvania, 17110

  • Southern Heart Center

    Hattiesburg, Mississippi, 39401

  • Frye Regional Medical Center

    Hickory, North Carolina, 28601

  • St. Mary's Medical

    Hobart, Indiana, 46342

  • Texas Heart Institute - St. Luke's Episcopal Hospital

    Houston, Texas, 77030

  • Citrus Memorial Hospital

    Inverness, Florida, 34452

  • Osceola Regional Medical Center

    Kissimmee, Florida, 34741

  • University of Tenn. Medical Center - Knoxville

    Knoxville, Tennessee, 37920

  • Sparrow Hospital

    Lansing, Michigan, 48910

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060

  • University of Miami

    Miami, Florida, 33136

  • Aurora Health Care

    Milwaukee, Wisconsin, 53215

  • P and S Surgical Hospital

    Monroe, Louisiana, 71201

  • Community Hospital, Munster

    Munster, Indiana, 46321

  • St. Margaret Mercy

    Munster, Indiana, 46321

  • St. Luke's - Roosevelt Hospital

    New York, New York, 10025

  • Newark Beth Israel Hospital

    Newark, New Jersey, 07112

  • Alegent Health

    Omaha, Nebraska, 68124

  • Orlando Regional Hospital

    Orlando, Florida, 32806

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Valley Hospital

    Ridgewood, New Jersey, 07450

  • Trinity Medical Center

    Rock Island, Illinois, 61201

  • William Beaumont Hospital

    Royal Oak, Michigan, 48073

  • Penninsula Regional Medical Center

    Salisbury, Maryland, 21804

  • NE Methodist

    San Antonio, Texas, 78258

  • Arizona Heart Hospital

    Scottsdate, Arizona, 85251

  • Our Lady of Lourdes Hospital

    Sewell, New Jersey, 08080

  • St. John's Hospital

    Springfield, Illinois, 62769

  • Tallahassee Memorial Hospital

    Tallahassee, Florida, 32308

  • Community Memorial Hospital

    Ventura, California, 93003

  • Watsonville Community Hospital

    Watsonville, California, 95076

  • Landmark Medical Center

    Woonsocket, Rhode Island, 02895

  • University of Massachusetts Medical School

    Worcester, Massachusetts, 01655

  • York Hospital

    York, Pennsylvania, 17403

  • Catholic Health Partners

    Youngstown, Ohio, 44510

Other trials in United States

About this study

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

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.

Read the 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.

Keywords
Pacemaker infection, Defibrillator infection, ICD infection, CRT infection, Cardiovascular implantable electronic device infection, Infection, Pacemaker, Artificial, Defibrillators
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01043705
Study groupRoleWhat they receive
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 ArmPatients 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)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major CIED Infection

    CIED Major Infections

    Measured: 12 months

  2. CIED Mechanical Complication

    All mechanical Complications related to CIED Implant

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionJul 2014
  4. Study completionMay 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
1,262 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01043705
Sponsor's protocol ID
CP-2009-2
Acronym
Centurion
Status last verified
Oct 2015
First submitted
5 Jan 2010
Last updated
24 Dec 2015
Data monitoring committee
Yes

Publications

  • Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Comparison of mortality in women versus men with infections involving cardiovascular implantable electronic device. Am J Cardiol. 2013 Nov 1;112(9):1403-9. doi: 10.1016/j.amjcard.2013.06.031. Epub 2013 Aug 22.

    PubMed 23972346

  • Ballo P, Chiodi L, Zuppiroli A. Cardiac implantable electronic devices: prevention starts from ethics. Arch Intern Med. 2012 Apr 23;172(8):670-1; author reply 671-2. doi: 10.1001/archinternmed.2012.346. No abstract available.

    PubMed 22529239

  • Henrikson CA, Sohail MR, Acosta H, Johnson EE, Rosenthal L, Pachulski R, Dan D, Paladino W, Khairallah FS, Gleed K, Hanna I, Cheng A, Lexcen DR, Simons GR. Antibacterial Envelope Is Associated With Low Infection Rates After Implantable Cardioverter-Defibrillator and Cardiac Resynchronization Therapy Device Replacement: Results of the Citadel and Centurion Studies. JACC Clin Electrophysiol. 2017 Oct;3(10):1158-1167. doi: 10.1016/j.jacep.2017.02.016. Epub 2017 May 31.

    PubMed 29759500

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Implantable Electronic Device Infection, run by TYRX, Inc. at 52 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major CIED Infection (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01043705, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.

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