NCT00336284

TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,450 (actual)
• Sponsor: Biotronik, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Patient Indicated for an ICD

Interventions

Type	Name	Description
OTHER	Home Monitoring	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.
OTHER	In-Office Conventional Follow-up	Home Monitoring programmed off. In-office evaluations at 3, 6, 9, 12, and 15 months post ICD implant.

Timeline

• Start date: 2005-11-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2006-06-13
• Last updated: 2010-08-03
• Results posted: 2010-03-30

Locations

110 sites across 2 countries: United States, Canada