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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 is a Phase 4 study that has completed, run by Biotronik. The registered enrollment target is 221 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00396136
The ClinicalTrials.gov registry entry for NCT00396136 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 221 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biotronik, which has 30 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Corox OTW Steroid Left Ventricular Lead is the first listed.
NCT00396136 reports 0 study locations.
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.
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