Clinical trial NCT00396136: COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
Official title: Corox OTW Steroid LV Lead Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Cardiac Resynchronization Therapy
Left Ventricular Lead
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

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 enrolling physician according to the detailed inclusion and exclusion criteria below.

The specific required visits for this registry are: Enrollment, Three-month, Six month, One-year, Routine Follow-Ups (every subsequent 6 months), Interim follow-ups for Corox OTW Steroid LV lead related visits, and Out of Service visit. Data will be collected at each patient follow-up. The programmed pacing parameters, LV pacing impedance, and LV pacing threshold measurement at 0.5ms pulse width will be obtained. The programming parameters will be set to best suit each patient. If adequate system function, including effective CRT, cannot be obtained, the patient should not be selected for the registry.

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

Primary outcomes:
measure: Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing
timeFrame: All follow-ups for 3 years post implant
measure: Safety of the COROX OTW Steroid LV Pacing Lead
timeFrame: 3 years post implant
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Oswego
country: United States
facility: Biotronik
state: Oregon
Study officials:
affiliation: Biotronik, Inc.
name: Katerina de Metz
role: STUDY_DIRECTOR
References: