Evaluation of Left Ventricular AutoThreshold (ELEVATE)
This study will collect data on a new feature for future heart failure devices via an external non-implantable system.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of Left Ventricular AutoThreshold|
- The objective of this study is to collect data to characterize the performance of the LVAT feature. [ Time Frame: Implant ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Device: No intervention is used. Collection of signals only.
Device received per standard of care.
ELEVATE is an acute, prospective, multi-center, feasibility study with a randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold feature.
|United States, Virginia|
|Virginia Commonwealth University Health System|
|Richmond, Virginia, United States, 23298|
|United States, West Virginia|
|Monongalia General Hospital|
|Morgantown, West Virginia, United States, 26505|
|Principal Investigator:||Kenneth L. Ellenbogen, M.D.||Virginia Commonwealth University Health System|