CompletedNot Applicable

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

United States1,262 participantsStarted 2010-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. ≥ 12 months follow-up after Qualifying TYRX Implant
✕. 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)
✕. Death ≤ 12 months after Qualifying CIED Implant

What they're measuring

Major CIED Infection

Timeframe: 12 months

CIED Mechanical Complication

Timeframe: 12 months

Trial details

NCT IDNCT01043705

SponsorTYRX, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-07

Results submitted2015-10-13

View on ClinicalTrials.gov More Cardiac Implantable Electronic Device Infection trials