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

Completed · Phase 4

Conditions studied: Patient Indicated for an ICD

In brief

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.

Key facts

Study ID

NCT00336284

Run by

Biotronik, Inc.

People needed

1450

Starts

2005-11-01

Expected to finish

2009-06-01

Last updated by the study team

2010-08-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Implanted within the last 45 days or being considered for implant with a BIOTRONIK ICD with Home Monitoring (HM)/Intracardiac Electrogram (IEGM)-Online technology, or legally marketed future generation device with HM/IEGM Online.
• Able to utilize the HM system throughout the study
• Ability to give informed consent
• Geographically stable and able to return for regular follow-ups for fifteen (15) months
• At least 18 years old

You may not qualify if…

• Patients who do not fulfill all inclusion criteria
• Pacemaker dependent
• Currently enrolled in any other cardiac clinical investigation

Where it is running

• Site 68 — Mesa, Arizona, United States
• Site 99 — Phoenix, Arizona, United States
• Site 118 — Bakersfield, California, United States
• Site 91 — Bakersfield, California, United States
• Site 95 — Burbank, California, United States
• Site 72 — Fairfield, California, United States
• Site 43 — Fremont, California, United States
• Site 90 — Fresno, California, United States
• Site 73 — Fresno, California, United States
• Site 75 — Fresno, California, United States
• Site 67 — Glendale, California, United States
• Site 82 — Jackson, California, United States
• Site 78 — Mission Viejo, California, United States
• Site 15 — Sherman Oaks, California, United States
• Site 89 — Simi Valley, California, United States
• Site 88 — Whittier, California, United States
• Site 37 — Boulder, Colorado, United States
• Site 38 — Boulder, Colorado, United States
• Site 98 — Denver, Colorado, United States
• Site 122 — Newark, Delaware, United States
• Site 100 — Brooksville, Florida, United States
• Site 111 — Jacksonville, Florida, United States
• Site 40 — Lakeland, Florida, United States
• Site 36 — Lauderdale Lakes, Florida, United States
• Site 55 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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