Response of Cardiac Resynchronization Therapy Optimization With Ventricle to Ventricle Timing in Heart Failure Patients

Study Methods

- This is a prospective, randomized (simultaneous biventricular (BiV) pacing vs.
sequential BiV pacing) study.

- Any patient that receives an FDA approved St. Jude Medical (SJM) CRT-D with V-V timing
is eligible for enrollment.

- At 3 months post enrollment (or at implant for CRT-D replacements), patients screened as
non-responders are randomized to either simultaneous or sequential BiV pacing. Patients
requiring a replacement CRT-D device that are identified as non-responders to CRT are
enrolled at the screening/randomization visit.

- Patients are followed for a period of 6 months post randomization:

- Enrollment (1 week pre CRT-D implant to < 2 weeks post CRT-D implant)

- Screening/Randomization Visit (3 months post enrollment)

- Follow-up Visit (6 months post randomization)

- Total # of centers - 80 centers

- Sample size - 800 patients screened for CRT non-responders

Inclusion Criteria:

- Patient has a standard indication for a CRT-D.

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

- Patient is geographically stable and willing to comply with the required follow-up
schedule.

- Prior to 1 month of randomization, patient's HF medications are maintained stable and
remain stable throughout the study.

- Patients requiring a CRT-D replacement must comply with BOTH of the following:

- > 1 HF related hospitalization

- No class improvement or worsening in NYHA scale

Exclusion Criteria:

- Patient's life expectancy is less than 12 months.

- Patient has had cardiac surgery within 6 months of enrollment.

- Patient has an epicardial ventricular lead system.

- Patient is less than 18 years old.

- Patient is pregnant.