COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring - Full Text View

Sponsored by:	Biotronik, Inc.
Information provided by:	Biotronik, Inc.
ClinicalTrials.gov Identifier:	NCT00396136

Purpose

The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox OTW Steroid LV lead as used in conjunction with a BIOTRONK 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

Condition	Intervention	Phase
Congestive Heart Failure	Device: Corox OTW Steroid Left Ventricular Lead	Phase IV

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Corox OTW Steroid LV Lead Monitoring

Further study details as provided by Biotronik, Inc.:

Primary Outcome Measures:

Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
Safety of the COROX OTW Steroid LV pacing lead [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1000
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Intervention Details:

This is a registry: no study required interventions necessary.

Detailed Description:

This post approval registry will include approximately 1000 patients from 100 centers. The collection of registry data will continue for three years for each enrolled subject. Potential patients are 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396136

Contacts

Contact: Matt Jenkins, MS	(503) 387 2606	matt.jenkins@biotronik.com
Contact: Katerina de Metz, MS	(503) 675 2169	katerina.demetz@biotronik.com

Locations

United States, Oregon
BIOTRONIK	Recruiting
Lake Oswego, Oregon, United States, 97035

Sponsors and Collaborators

Biotronik, Inc.

Investigators

Study Director:

Katerina de Metz

Biotronik, Inc.

More Information

Responsible Party:	BIOTRONIK, Inc ( Matt Jenkins/ Senior Clinical Studies Engineer )
Study ID Numbers:	20061550
Study First Received:	November 1, 2006
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00396136
Health Authority:	United States: Institutional Review Board

Keywords provided by Biotronik, Inc.:

Congestive Heart Failure
Cardiac Resynchronization Therapy
Left Ventricular Lead

Study placed in the following topic categories:

Heart Failure
Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009