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NCT00810264 · ClinicalTrials.gov registry record
Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
A clinical trial, sponsored by Biotronik.
- Completed
- Registry status
- 2,499
- Enrollment target
NCT00810264: Completed study, sponsored by Biotronik.
NCT00810264 is a clinical trial that has completed, run by Biotronik. The registered enrollment target is 2,499 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00810264 has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- 2,499 participants
- Enrollment target
Study Summary
The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.
Primary Outcome
The overall incidence of serious adverse events that require additional invasive intervention to resolve, related to the Corox BP LV leads implanted with either BIOTRONIK CRT-P or CRT-D devices.This was evaluated as a serious adverse event free-rate (SAEFR).
Interventions
- DEVICE CRT Therapy - LV Lead Registry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,499 participants |
| Start Date | 2008-12 |
| Est. Completion | 2018-11-02 |
What the finished NCT00810264 record still lists
NCT00810264 is an observational study that tracks outcomes without assigning an intervention. Its 2,499 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 1 intervention - of which CRT Therapy - LV Lead Registry is the first listed.
NCT00810264 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00810264 about?
NCT00810264 is a clinical study titled "Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar". The objective of this study is to confirm the long-term safety and reliability of the Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.
What is the current status of trial NCT00810264?
This trial is currently completed. The enrollment target is 2,499 participants. The study started on 2008-12. Estimated completion is 2018-11-02.
What interventions are being tested in trial NCT00810264?
The interventions under investigation include: CRT Therapy - LV Lead Registry (DEVICE).
Who is sponsoring clinical trial NCT00810264?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
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