CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,997 enrolled
Drug / intervention
ICD Therapy - ICD 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/NCT00836589
NCT00836589N/ACompleted

GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry

Biotronik, Inc.·observational·Posted Feb 4, 2009·Updated Feb 15, 2019

In Brief

An observational study evaluating ICD Therapy - ICD Lead Registry for Patients Indicated for an ICD. Completed, enrolled 1,997 participants across 85 sites.

Detailed Summary

The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing pacing or defibrillation therapy.

Study Details

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

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 4, 2009
Enrollment StartDec 1, 2008
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 8 yearsPosted 17.4 years ago

Interventions

ICD Therapy - ICD Lead Registrydevice

Collecting long-term safety and efficacy data on a family of market-released ICD leads.