CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,262 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01043705
NCT01043705N/ACompleted

Centurion and Citadel Studies of TYRX™ Anti-Bacterial Envelope and Custom Mesh for Prevention of Infection Following CIED Replacement With a CRT or ICD

TYRX, Inc.·observational·Posted Jan 7, 2010·Updated Dec 24, 2015

In Brief

An observational study for Cardiac Implantable Electronic Device Infection. Completed, enrolled 1,262 participants across 52 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 7, 2010
Enrollment StartJan 1, 2010
Primary CompletionJul 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 16.5 years ago