CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 1,450 enrolled
Drug / intervention
Home Monitoring +1 moreother
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/NCT00336284
NCT00336284Phase 4Completed
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TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

Biotronik, Inc.·interventional·Posted Jun 13, 2006·Updated Aug 3, 2010

In Brief

A Phase 4 clinical trial evaluating Home Monitoring and In-Office Conventional Follow-up for Patient Indicated for an ICD. Completed, enrolled 1,450 participants across 110 sites in 2 countries.

Detailed Summary

This study is a multi-center, prospective and randomized trial. The primary objective of this study is to demonstrate that the use of the BIOTRONIK Home Monitoring system (HM) can safely reduce the number of regularly scheduled office follow-up visits, compared to the conventional method of implantable cardioverter defibrillator (ICD) follow-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPatient Indicated for an ICD
CountriesCanada, United States
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 13, 2006
Enrollment StartNov 1, 2005
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 20.1 years ago

Interventions

Home Monitoringother

Home Monitoring programmed on. In-office and Home Monitoring evaluation at 3 and 15 months post ICD implant. Home Monitoring evaluation only at 6, 9, and 12 months post ICD implant.

In-Office Conventional Follow-upother

Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.