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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500838
|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|