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

Completed

Conditions: Cardiac Implantable Electronic Device Infection

Registration Number: NCT01043705

Lead Sponsor: TYRX, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1262

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CIED Mechanical Complication	12 months	All mechanical Complications related to CIED Implant
Major CIED Infection	12 months	CIED Major Infections

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (52): Veteran's Administration Medical Center
🇺🇸
Atlanta, Georgia, United States
University of Maryland Medical Center
🇺🇸
Baltimore, Maryland, United States
University of Miami
🇺🇸
Miami, Florida, United States
Decatur General Hospital
🇺🇸
Decatur, Alabama, United States
Eliza Coffee Memorial Hospital
🇺🇸
Florence, Alabama, United States
Watsonville Community Hospital
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Watsonville, California, United States
Riverview Regional Hospital
🇺🇸
Gadsden, Alabama, United States
Arizona Heart Hospital
🇺🇸
Scottsdate, Arizona, United States
Community Memorial Hospital
🇺🇸
Ventura, California, United States
Citrus Memorial Hospital
🇺🇸
Inverness, Florida, United States
Osceola Regional Medical Center
🇺🇸
Kissimmee, Florida, United States
Piedmont Medical Center
🇺🇸
Atlanta, Georgia, United States
Wellstar Kennestone Hospital
🇺🇸
Marietta, Georgia, United States
Trinity Medical Center
🇺🇸
Rock Island, Illinois, United States
Emory University Hospital
🇺🇸
Atlanta, Georgia, United States
St. Margaret Mercy
🇺🇸
Munster, Indiana, United States
Community Hospital, Munster
🇺🇸
Munster, Indiana, United States
St. John's Hospital
🇺🇸
Springfield,, Illinois, United States
St. Mary's Medical
🇺🇸
Hobart, Indiana, United States
P and S Surgical Hospital
🇺🇸
Monroe, Louisiana, United States
Johns Hopkins University Hospital
🇺🇸
Baltimore, Maryland, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
Penninsula Regional Medical Center
🇺🇸
Salisbury, Maryland, United States
University of Massachusetts Medical School
🇺🇸
Worcester, Massachusetts, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Keesler Air Force Base Hospital
🇺🇸
Biloxi, Mississippi, United States
Sparrow Hospital
🇺🇸
Lansing, Michigan, United States
Gulfport Memorial Hospital
🇺🇸
Biloxi, Mississippi, United States
Southern Heart Center
🇺🇸
Hattiesburg, Mississippi, United States
Valley Hospital
🇺🇸
Ridgewood, New Jersey, United States
Englewood Hospital and Medical Center
🇺🇸
Englewood, New Jersey, United States
Newark Beth Israel Hospital
🇺🇸
Newark, New Jersey, United States
St. Francis Hospital
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Hamilton, New Jersey, United States
Frye Regional Medical Center
🇺🇸
Hickory, North Carolina, United States
Our Lady of Lourdes Hospital
🇺🇸
Sewell, New Jersey, United States
St. Luke's - Roosevelt Hospital
🇺🇸
New York, New York, United States
Catholic Health Partners
🇺🇸
Youngstown, Ohio, United States
Pinnacle Health Harrisburg Hospital
🇺🇸
Harrisburg, Pennsylvania, United States
Doylestown Hospital
🇺🇸
Doylestown, Pennsylvania, United States
York Hospital
🇺🇸
York, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Landmark Medical Center
🇺🇸
Woonsocket, Rhode Island, United States
Texas Heart Institute - St. Luke's Episcopal Hospital
🇺🇸
Houston, Texas, United States
NE Methodist
🇺🇸
San Antonio, Texas, United States
Henry Ford Health System
🇺🇸
Detroit, Michigan, United States
Tallahassee Memorial Hospital
🇺🇸
Tallahassee, Florida, United States
University of Tenn. Medical Center - Knoxville
🇺🇸
Knoxville, Tennessee, United States
Stern Cardiovascular Foundation
🇺🇸
Germantown, Tennessee, United States
Princeton Medical Center
🇺🇸
Birmingham, Alabama, United States
Orlando Regional Hospital
🇺🇸
Orlando, Florida, United States
Alegent Health
🇺🇸
Omaha, Nebraska, United States
Aurora Health Care
🇺🇸
Milwaukee, Wisconsin, United States