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.