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Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)

NCT00836589 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing pacing or defibrillation therapy.

Interventions

  • DEVICE ICD Therapy - ICD Lead Registry

Study Locations (20)

California

  • — Burbank
  • — Fairfield
  • — Fountain Valley
  • — Glendale
  • — Hawthorne
  • — Inglewood
  • — Los Angeles
  • — Mission Viejo
  • — Northridge
  • — Rancho Mirage
  • — Santa Barbara

Arizona

  • — Glendale
  • — Mesa
  • — Phoenix
  • — Scottsdale
  • — Tucson

Alabama

  • — Albertville
  • — Birmingham
  • — Gadsden
  • — Jasper

Trial Details

FieldValue
Enrollment Target 1,997 participants
Start Date 2008-12
Est. Completion 2016-12

Sponsor

Biotronik

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00836589

The ClinicalTrials.gov registry entry for NCT00836589 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 1,997 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 Patients Indicated for an ICD appearing as the primary indexed condition, and to 1 intervention — of which ICD Therapy - ICD Lead Registry 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: NCT00836589 reports 20 study locations spanning 3 distinct geographic areas — top geographies include California, Arizona, Alabama. 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 NCT00836589 about?

NCT00836589 is a clinical study titled "Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)". The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing p...

What is the current status of trial NCT00836589?

This trial is currently completed. The enrollment target is 1,997 participants. The study started on 2008-12. Estimated completion is 2016-12.

What conditions does trial NCT00836589 study?

This clinical trial studies the following conditions: Patients 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 NCT00836589?

The interventions under investigation include: ICD Therapy - ICD Lead Registry (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00836589?

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 NCT00836589 being conducted?

This trial has 20 study locations across Alabama, Arizona, California. 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