Phase 4 Completed N=221 Treatment

COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

Heart Failure

Source: ClinicalTrials.gov NCT00396136 ↗

Enrolled (actual)

221

Serious AEs

4.1%

Results posted

May 2012

Primary outcomePrimary: Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing — 1.3 Threshold Voltage

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing	1.3	—
PRIMARY Safety of the COROX OTW Steroid LV Pacing Lead	9	—

Eligibility Criteria

Inclusion Criteria

Successfully implanted BIOTRONIK CRT-D system, including the Corox OTW Steroid LV Lead, from 1-30 days prior to enrollment
Able to understand the nature of the registry and give informed consent
Available for follow-up visits on a regular basis at the investigational site
Age greater than or equal to 18 years

Exclusion Criteria

Enrolled in another cardiovascular or pharmacological clinical investigation
Planned cardiac surgical procedures or interventional measures within the next 6 months
Expected to receive a heart transplant within 6 months
Life expectancy less than 6 months
Presence of another life-threatening, underlying illness separate from their cardiac disorder
Pregnancy

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00396136). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.