Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00273182
Status:
COMPLETED
Last Update Posted:
2013-08-05
First Post:
2006-01-04
Brief Title:
InSync Model 8040 InSync and InSync III Model 8042 InSync III Registry
Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Organization:
Medtronic Cardiac Rhythm and Heart Failure
Study Overview
Official Title:
InSync Model 8040 InSync and InSync III Model 8042 InSync III Systems for Cardiac Resynchronization Therapy CRT - InSync Registry
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Heart failure is a progressive disease that decreases the pumping action of the heart This may cause a backup of fluid in the heart and may result in heart beat changes
When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat In certain heart failure cases when the two lower chambers of the heart no longer beat in a coordinated manner cardiac resynchronization therapy CRT may be prescribed CRT is similar to a pacemaker It is placed implanted under the skin of the upper chest CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads soft insulated wires that are inserted through the veins to the heart
The purpose of this study is to monitor the long-term performance of the InSync Model 8040 InSync and InSync III Model 8042 InSync III systems for cardiac resynchronization therapy CRT
When there are changes in the heart beat sometimes an implantable heart device is used to control the rate and rhythm of the heart beat In certain heart failure cases when the two lower chambers of the heart no longer beat in a coordinated manner cardiac resynchronization therapy CRT may be prescribed CRT is similar to a pacemaker It is placed implanted under the skin of the upper chest CRT is delivered as tiny electrical pulses to the right and left ventricles through three or four leads soft insulated wires that are inserted through the veins to the heart
The purpose of this study is to monitor the long-term performance of the InSync Model 8040 InSync and InSync III Model 8042 InSync III systems for cardiac resynchronization therapy CRT
Detailed Description:
Condition of Approval study for cardiac resynchronization therapy with pacemakers and for the Attain left ventricular leads 2187 2188 4193 and 4194
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