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

Cardiac Implantable Electronic Device Infection Clinical Trial

— Centurion  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01043705
• Other study ID #: CP-2009-2
• Status: Completed
• Phase: N/A
• First received: January 5, 2010
• Last updated: November 20, 2015
• Start date: January 2010
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: TYRX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 defibrilator (ICD) and TYRX Anti-Bacterial Envelope (formerly known as "AIGISRx"), to the incidence, after replacement with an ICD or CRT and no TYRX.

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.

Other known NCT identifiers

• NCT01043861

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: May 2015
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Implantable Electronic Device Infection
• Communicable Diseases
• Infection

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
TYRX, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major CIED Infection	CIED Major Infections	12 months	No
Primary	CIED Mechanical Complication	All mechanical Complications related to CIED Implant	12 months	No