BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement

NATerminatedINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Heart Failure
Interventions
DEVICE

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.

DEVICE

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.

Trial Locations (2)

39401

Hattiesburg Clinic, P.A./Southern Heart Center, Hattiesburg

80045

University of Colorado Hospital, Aurora

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY