Cardiac Implantable Electronic Device Infection Clinical Trial
— CenturionOfficial 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
Verified date | October 2015 |
Source | TYRX, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
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 |
Observational Model: Case Control, Time Perspective: Prospective
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 |
Lead Sponsor | Collaborator |
---|---|
TYRX, Inc. |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05958290 -
Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See
|
N/A | |
Not yet recruiting |
NCT06323668 -
Cardiac Implantable Electronic Device remOval Versus Full coUrse Medical Treatment
|
N/A | |
Completed |
NCT05576194 -
Taurolidine Containing Antimicrobial CIED Wash to Prevent Infection
|
||
Completed |
NCT03842124 -
Improving Safety of Lead Extraction Procedures by Traction Force Sensing
|
N/A |