FREEDOM - A Frequent Optimization Study Using the QuickOpt Method

- 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.

Inclusion Criteria:

- Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM)
CRT¬D device with VV timing and a compatible lead system.

- Patient has the ability to complete a 6-minute hall walk with the only limiting factor
to be fatigue or shortness of breath.

- Patient has the ability to independently comprehend and complete a QOL questionnaire.

Exclusion Criteria:

- Patient has an epicardial ventricular lead system.

- Patient has the ability to walk ≥ 450 meters in 6 minutes

- Patient has limited intrinsic atrial activity (≤ 40 bpm).

- Patient has persistent or permanent atrial fibrillation (AF).

- Patient has a 2° or 3° heart block.

- Patient's life expectancy is less than 1 year.

- Patient is pregnant.

- Patient is on IV inotropic agents.