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NCT00836589 · ClinicalTrials.gov registry record
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
A clinical trial of Patients Indicated for an ICD, sponsored by Biotronik.
- Completed
- Registry status
- 1,997
- Enrollment target
- 20
- Study locations
NCT00836589: Completed study of Patients Indicated for an ICD, sponsored by Biotronik.
NCT00836589 is a study of Patients Indicated for an ICD that has completed, run by Biotronik. The registered enrollment target is 1,997 participants. The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00836589, a study of Patients Indicated for an ICD, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- 1,997 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 1,997 participants |
| Start Date | 2008-12 |
| Est. Completion | 2016-12 |
What the finished NCT00836589 record still lists
NCT00836589 is an observational study that tracks outcomes without assigning an intervention. Its 1,997 participants enrollment target places it among the larger protocols in the corpus.
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.
NCT00836589 names 20 study sites across 3 states, led by California, Arizona, Alabama.
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.
What interventions are being tested in trial NCT00836589?
The interventions under investigation include: ICD Therapy - ICD Lead Registry (DEVICE).
Who is sponsoring clinical trial NCT00836589?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
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.
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