COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

Study Overview
=================
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.

Official Title
-----------------
Corox OTW Steroid LV Lead Monitoring

Conditions
-----------------
Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Corox OTW Steroid Left Ventricular Lead


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Corox OTW Steroid Left Ventricular Lead|This is a registry: no study required interventions necessary.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing | Evaluate threshold voltage of the COROX OTW Unipolar Lead. | All follow-ups for 3 years post implant | 
| Safety of the COROX OTW Steroid LV Pacing Lead | Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve. | 3 years post implant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congestive Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Lead