COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00396136
First received: November 1, 2006
Last updated: April 27, 2012
Last verified: April 2012

November 1, 2006
April 27, 2012
October 2006
December 2011   (final data collection date for primary outcome measure)
  • Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing [ Time Frame: All follow-ups for 3 years post implant ] [ Designated as safety issue: No ]
    Evaluate threshold voltage of the COROX OTW Unipolar Lead.
  • Safety of the COROX OTW Steroid LV Pacing Lead [ Time Frame: 3 years post implant ] [ Designated as safety issue: Yes ]
    Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.
  • Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing
  • Safety of the COROX OTW Steroid LV pacing lead
Complete list of historical versions of study NCT00396136 on ClinicalTrials.gov Archive Site
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COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
Corox OTW Steroid LV Lead Monitoring

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

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Congestive Heart Failure
Device: Corox OTW Steroid Left Ventricular Lead
This is a registry: no study required interventions necessary.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
221
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00396136
20061550
Not Provided
Biotronik, Inc.
Biotronik, Inc.
Not Provided
Study Director: Katerina de Metz Biotronik, Inc.
Biotronik, Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP