Evaluation of Left Ventricular Autothreshold, Phase Two (ELEVATE 2)
This study will collect data, from an implanted Cardiac Resynchronization Therapy-Defibrillator (CRT-D) device, to further evaluate a new feature for future heart failure devices.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Evaluation of Left Ventricular Autothreshold, Phase Two|
- Collect ventricular evoked response signals and CRT-D device data during LV only and Bi-ventricular (Bi-V) voltage step down pacing [ Time Frame: At least 24 hours post CRT-D implant ] [ Designated as safety issue: No ]The primary objective of this study is to collect real-time signals during LV pacing voltage step-down from patients with implanted COGNIS CRT-D devices in a follow-up setting. This data will be used to assess the stability of the LV evoked response electrogram signal and will be used in an offline assessment of the LVAT algorithm. One or two data points will be collected per patient in the trial. Patients must be at least 24 hours post implant of their COGNIS CRT-D device
|Study Start Date:||November 2010|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Two experimental and/or intervention groups under 1 arm.
Cardiac pacing via a pulse generator and implanted intracardiac leads
ELEVATE 2.0 is an acute, prospective, multi-center, feasibility study randomized within patient test sequence and pulse width, designed to characterize the performance of the Left Ventricular Auto Threshold (LVAT) feature.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242722
|United States, Ohio|
|Regional Cardiovascular Medical Center|
|Stuebenville, Ohio, United States, 43952|
|Principal Investigator:||Kenneth L Ellenbogen, M.D.||Virginia Commonwealth University Health System|