Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00500838
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2007-07-11
Brief Title:
Cardiac Resynchronization Therapy Defibrillator Based Impedance Monitoring Study
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
CRT-D Based Impedance Monitoring Feasibility Study
Status:
COMPLETED
Status Verified Date:
2019-01
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 intent of this feasibility study is to collect and analyze intra-thoracic impedance measurements from a CRT-D device in a heart failure population
Detailed Description:
This is a multi-center feasibility study intended to collect information on changes in intra-thoracic impedance measurements from CRT-D devices In order to obtain an intra-thoracic impedance measurement the device delivers a subthreshold impulse that measures the resistance between two electrodes
At the programmed interval measurements will be obtained between six different lead configurations
At the programmed interval measurements will be obtained between six different lead configurations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None