COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

Completed · Phase 4

Conditions studied: Congestive Heart Failure

In brief

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

Key facts

Study ID

NCT00396136

Run by

Biotronik, Inc.

People needed

221

Starts

2006-10-01

Expected to finish

2011-12-01

Last updated by the study team

2012-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Biotronik — Lake Oswego, Oregon, United States

Full record on ClinicalTrials.gov

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