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COMPLETED Phase 4

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

NCT00336284 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,450 participants
Start Date 2005-11
Est. Completion 2009-06
Phase Phase 4

Sponsor

Biotronik

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00336284

The ClinicalTrials.gov registry entry for NCT00336284 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biotronik, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00336284 reports 20 study locations spanning 4 distinct geographic areas — top geographies include California, Colorado, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00336284?

The interventions under investigation include: Home Monitoring (OTHER), In-Office Conventional Follow-up (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00336284?

This trial is sponsored by Biotronik, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial