CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,499 enrolled
Drug / intervention
CRT Therapy - LV Lead Registrydevice
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/NCT00810264
NCT00810264N/ACompleted

CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry

Biotronik, Inc.·observational·Posted Dec 18, 2008·Updated Nov 29, 2019

In Brief

An observational study evaluating CRT Therapy - LV Lead Registry for Congestive Heart Failure. Completed, enrolled 2,499 participants across 86 sites.

Detailed Summary

The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

Study Details

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

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 18, 2008
Enrollment StartDec 1, 2008
Primary CompletionNov 2, 2018
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 17.5 years ago

Interventions

CRT Therapy - LV Lead Registrydevice

Collecting long-term safety and efficacy data on a market-released left ventricular lead.