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NCT00396136 · ClinicalTrials.gov registry record · Phase 4
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
A Phase 4 study, sponsored by Biotronik.
- Completed
- Registry status
- Phase 4
- Development phase
- 221
- Enrollment target
NCT00396136: Completed Phase 4 study, sponsored by Biotronik.
NCT00396136 is a Phase 4 study that has completed, run by Biotronik. The registered enrollment target is 221 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00396136, a Phase 4 study, has completed, sponsored by Biotronik.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 221 participants
- Enrollment target
Study Summary
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left ventricle in a CRT-D system. The following are the specific objectives to be evaluated during this post-approval registry: * Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing * Safety of the COROX OTW Steroid LV pacing lead
Primary Outcome
Evaluate threshold voltage of the COROX OTW Unipolar Lead.
Interventions
- DEVICE Corox OTW Steroid Left Ventricular Lead
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 221 participants |
| Start Date | 2006-10 |
| Est. Completion | 2011-12 |
| Phase | Phase 4 |
What the finished NCT00396136 record still lists
NCT00396136 is an interventional study that assigns participants to a tested intervention. The registered 221 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 1 intervention - of which Corox OTW Steroid Left Ventricular Lead is the first listed.
NCT00396136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00396136 about?
NCT00396136 is a clinical study titled "COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring". The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capab...
What is the current status of trial NCT00396136?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 221 participants. The study started on 2006-10. Estimated completion is 2011-12.
What interventions are being tested in trial NCT00396136?
The interventions under investigation include: Corox OTW Steroid Left Ventricular Lead (DEVICE).
Who is sponsoring clinical trial NCT00396136?
This trial is sponsored by Biotronik, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00396136's enrollment target sits among peer trials
221 383rd of 2000 higher than 1,616 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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