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NCT00336284 · ClinicalTrials.gov registry record · Phase 4
TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up
A Phase 4 study of Patient Indicated for an ICD, sponsored by Biotronik.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,450
- Enrollment target
- 20
- Study locations
NCT00336284: Completed Phase 4 study of Patient Indicated for an ICD, sponsored by Biotronik.
NCT00336284 is a Phase 4 study of Patient Indicated for an ICD that has completed, run by Biotronik. The registered enrollment target is 1,450 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (180% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00336284, a Phase 4 study of Patient Indicated for an ICD, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,450 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Average number of office-based implantable cardioverter defibrillator (ICD) follow-up visits in the Home Monitoring arm vs the Conventional (calendar-based) follow-up arm.
Conditions Studied
Interventions
- OTHER Home Monitoring
- OTHER In-Office Conventional Follow-up
Study Locations (20)
California
- Site 118 - Bakersfield
- Site 91 - Bakersfield
- Site 95 - Burbank
- Site 72 - Fairfield
- Site 43 - Fremont
- Site 90 - Fresno
- Site 73 - Fresno
- Site 75 - Fresno
- Site 67 - Glendale
- Site 82 - Jackson
- Site 78 - Mission Viejo
- Site 15 - Sherman Oaks
- Site 89 - Simi Valley
- Site 88 - Whittier
Colorado
- Site 37 - Boulder
- Site 38 - Boulder
- Site 98 - Denver
Arizona
- Site 68 - Mesa
- Site 99 - Phoenix
Alabama
- Site 55 - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,450 participants |
| Start Date | 2005-11 |
| Est. Completion | 2009-06 |
| Phase | Phase 4 |
What the finished NCT00336284 record still lists
NCT00336284 is an interventional study that assigns participants to a tested intervention. Its 1,450 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (180% higher).
The record links to 1 condition, with Patient Indicated for an ICD appearing as the primary indexed condition, and to 2 interventions - of which Home Monitoring is the first listed.
NCT00336284 names 20 study sites across 4 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT00336284 about?
NCT00336284 is a clinical study titled "TRUST: Lumos-T Safely RedUceS RouTine Office Device Follow-up". 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 implanta...
What is the current status of trial NCT00336284?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,450 participants. The study started on 2005-11. Estimated completion is 2009-06.
What conditions does trial NCT00336284 study?
This clinical trial studies the following conditions: Patient Indicated for an ICD.
What interventions are being tested in trial NCT00336284?
The interventions under investigation include: Home Monitoring (OTHER), In-Office Conventional Follow-up (OTHER).
Who is sponsoring clinical trial NCT00336284?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00336284 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00336284's enrollment target sits among peer trials
1,450 53rd of 2000 higher than 1,948 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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