OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Inclusion Criteria:

- NYHA Class III/IV

- Stable medical regimen

- QRS greater than or equal to 130 ms

- LVEF less than or equal to 35%

Exclusion Criteria:

- VT of transient or reversible causes

- Incessant VT

- Currently implanted with a lead positioned through the coronary sinus (unless it is
the SITUS OTW LV lead)

- Cardiac revascularization or angioplasty within the last month

- Heart failure due to correctable valve disease

- Chronic, medially refractory AT

- Enrolled in another clinical study that may confound the results of this study

- Life expectancy less than 6 months

- Inability to understand the purpose of the study or refusal to cooperate

- Inability or refusal to provide informed consent

- Unavailable for scheduled follow-up with the implanting practice

- Sensitivity to 1 mg dexamethasone sodium phosphate

- Less than 18 years of age

- Pregnancy