Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00396136
Status:
COMPLETED
Last Update Posted:
2012-05-28
First Post:
2006-11-01
Brief Title:
COSMO Post Approval Registry Corox OTW Steroid LV Lead Monitoring
Sponsor:
Biotronik Inc
Organization:
Biotronik Inc
Study Overview
Official Title:
Corox OTW Steroid LV Lead Monitoring
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 05ms 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
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 05ms 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None