Status:
COMPLETED
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
Lead Sponsor:
Biotronik, Inc.
Conditions:
Congestive Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 BIOT...
Detailed Description
This post approval registry enrolled 221 patients from 34 centers. The collection of registry data continued for three years for each enrolled subject. Potential patients were screened by the enrollin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
221 Patients enrolled
Trial Details
Trial ID
NCT00396136
Start Date
October 1 2006
End Date
December 1 2011
Last Update
May 28 2012
Active Locations (1)
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1
Biotronik
Lake Oswego, Oregon, United States, 97035