TYRX™ Envelope for Prevention of Infection Following Replacement With a CRT or ICD
Completed
Conditions studied: Cardiac Implantable Electronic Device Infection
In brief
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.
Key facts
- Study ID
- NCT01043705
- Run by
- TYRX, Inc.
- People needed
- 1262
- Starts
- 2010-01-01
- Expected to finish
- 2015-05-01
- Last updated by the study team
- 2015-12-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Decatur General Hospital — Decatur, Alabama, United States
- Eliza Coffee Memorial Hospital — Florence, Alabama, United States
- Riverview Regional Hospital — Gadsden, Alabama, United States
- Arizona Heart Hospital — Scottsdate, Arizona, United States
- Community Memorial Hospital — Ventura, California, United States
- Watsonville Community Hospital — Watsonville, California, United States
- Citrus Memorial Hospital — Inverness, Florida, United States
- Osceola Regional Medical Center — Kissimmee, Florida, United States
- University of Miami — Miami, Florida, United States
- Orlando Regional Hospital — Orlando, Florida, United States
- Tallahassee Memorial Hospital — Tallahassee, Florida, United States
- Piedmont Medical Center — Atlanta, Georgia, United States
- Emory University Hospital — Atlanta, Georgia, United States
- Veteran's Administration Medical Center — Atlanta, Georgia, United States
- Wellstar Kennestone Hospital — Marietta, Georgia, United States
- Trinity Medical Center — Rock Island, Illinois, United States
- St. John's Hospital — Springfield, Illinois, United States
- St. Mary's Medical — Hobart, Indiana, United States
- Community Hospital, Munster — Munster, Indiana, United States
- St. Margaret Mercy — Munster, Indiana, United States
- P and S Surgical Hospital — Monroe, Louisiana, United States
- University of Maryland Medical Center — Baltimore, Maryland, United States
- Johns Hopkins University Hospital — Baltimore, Maryland, United States
- Penninsula Regional Medical Center — Salisbury, Maryland, United States
- Princeton Medical Center — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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