COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

Biotronik

Status and phase: Completed; Phase 4

Conditions: Congestive Heart Failure

Treatments: Device: Corox OTW Steroid Left Ventricular Lead

Study type: Interventional

Funder types: Industry

Identifiers

NCT00396136

20061550

Details and patient eligibility

About

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

Full 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.

Enrollment: 221 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)