CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 221 enrolled
Drug / intervention
Corox OTW Steroid Left Ventricular Leaddevice
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/NCT00396136
NCT00396136Phase 4Completed
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Corox OTW Steroid LV Lead Monitoring

Biotronik, Inc.·interventional·Posted Nov 6, 2006·Updated May 28, 2012

In Brief

A Phase 4 clinical trial evaluating Corox OTW Steroid Left Ventricular Lead for Congestive Heart Failure. Completed, enrolled 221 participants across 1 site.

Detailed Summary

The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left ventricle in a CRT-D system. The following are the specific objectives to be evaluated during this post-approval registry: * Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing * Safety of the COROX OTW Steroid LV pacing lead

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongestive Heart Failure
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2006
Enrollment StartOct 1, 2006
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 19.7 years ago

Interventions

Corox OTW Steroid Left Ventricular Leaddevice

This is a registry: no study required interventions necessary.