17
Participants
Start Date
June 30, 2009
Primary Completion Date
September 30, 2010
Study Completion Date
September 30, 2010
QuickOpt - SJM CRT (Group 1)
The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed AV and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
Control - SJM CRT (Group 2)
The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
Hattiesburg Clinic, P.A./Southern Heart Center, Hattiesburg
University of Colorado Hospital, Aurora
Lead Sponsor
Abbott Medical Devices
INDUSTRY