COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

Congestive Heart Failure Clinical Trial

Official title:

Corox OTW Steroid LV Lead Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00396136
• Other study ID #: 20061550
• Status: Completed
• Phase: Phase 4
• First received: November 1, 2006
• Last updated: April 27, 2012
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: April 2012
• Source: Biotronik, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• Corox OTW Steroid Left Ventricular Lead
This is a registry: no study required interventions necessary.

Locations

Country	Name	City	State
United States	Biotronik	Lake Oswego	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes