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

NCT01043705 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1262

Last updated 2015-12-24

Study results available
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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.

Conditions

  • Cardiac Implantable Electronic Device Infection

Sponsors & Collaborators

  • TYRX, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-07-31
Completion
2015-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01043705 on ClinicalTrials.gov