CRT-D Based Impedance Monitoring Study
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||CRT-D Based Impedance Monitoring Feasibility Study|
- To assess the use of the impedance feature in conjunction with other functions of the CRT-D device [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||July 2007|
|Study Completion Date:||August 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Transthoracic impedance device implanted.
Device: Transthoracic Impedance
Impedance measures will be automatically collected via the device
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.
|United States, Arkansas|
|Baptist Health Medical Center|
|Little Rock, Arkansas, United States, 72205|
|United States, California|
|Glendale Memorial Hospital|
|Glendale, California, United States, 91204|
|United States, New Jersey|
|Deborah Heart and Lung|
|Browns Mills, New Jersey, United States, 08015|
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29401|
|Principal Investigator:||G. Stephen Greer, MD||Baptist Health|