Heart Failure Clinical Trial
Official title:
FREEDOM - A Frequent Optimization Study Using the QuickOpt Method
The objective of this study is to demonstrate that frequent atrio-ventricular (AV/PV) and inter-ventricular (V-V) delay optimization using QuickOpt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).
- This is a prospective, double-blinded, multicenter, randomized study
- Patient could be enrolled up to 2 weeks post CRT-D implant and are followed for 12
months post implant with follow-up visits at 3, 6, 9 and 12 months
- Patients will be randomized at enrollment to either Group 1 ("QuickOpt Group") or Group
2 ("Control Group").
- Group 1 - The patient's device is programmed to sequential biventricular pacing mode
with AV/PV and VV delays optimized using QuickOpt. For Group 1 patients, optimization
using QuickOpt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at
any unscheduled follow-up visits.
- Group 2 - The patient's device is programmed to either simultaneous or sequential BiV
pacing mode as per physician's discretion. The AV/PV and inter-ventricular (VV) delays
could be programmed empirically or optimized using any non-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 implant. Any AV/PV and VV delay optimizations performed after 4
weeks post implant in Group 2 patients will be considered protocol deviations.
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