COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring

NCT00396136 | Completed Phase 4 Results

• 1 other identifier: 20061550
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 1

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

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure; Cardiac Resynchronization Therapy; Left Ventricular Lead

Outcome Measures

Primary Outcomes (2)

• 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

Interventions

Corox OTW Steroid Left Ventricular Lead DEVICE

This is a registry: no study required interventions necessary.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotronik, Inc.: lead

Study Sites (1)

Biotronik

Lake Oswego, Oregon, 97035, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Clinical Studies
• Organization: Biotronik, Inc.

katerina.demetz@biotronik.com

503-451-8050

Study Officials

• Katerina de Metz

  Biotronik, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2006
• First Posted: November 6, 2006
• Study Start: October 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 28, 2012
• Results First Posted: May 28, 2012

Record last verified: 2012-04

Locations

US (1)