ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0 (ELEVATE 3)
This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to 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|
- Collect ventricular evoked response signal and CRT-D device data during LV only and Bi-Ventricular voltage step-down pacing. [ Time Frame: Minimum of 24 hrs post CRT-D implant. ] [ Designated as safety issue: No ]The primary objective of this study is to collect real-time signals during LV pacing and voltage step-down from patients with implanted COGNIS devices.
|Study Start Date:||March 2012|
|Study Completion Date:||November 2012|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
One group reflecting two different pulse widths.
Device: Cardiac pacing
Cadiac pacing via a pulse generator and implaned intracardiac leads.
Other Name: COGNIS PG.
ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.
|United States, Iowa|
|Genesis Medical Center|
|Davenport, Iowa, United States, 52803|
|United States, Pennsylvania|
|Cardiology Consultants of Philadelphia|
|Yardley, Pennsylvania, United States, 19067|
|United States, Virginia|
|Virginia Commonwealth University Health System|
|Richmond, Virginia, United States, 23298-0053|
|United States, Wisconsin|
|Wheaton Franciscan Health Care|
|Wauwatosa, Wisconsin, United States, 53226|
|Principal Investigator:||Kenneth L Ellenbogen, MD||Virginia Commonwealth University Health System|