OVATIO CRT and SITUS OTW LV Lead Post Approval Study
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Heart failure patients needing CRT therapy
NYHA Class III/IV
Stable medical regimen
QRS greater than or equal to 130 ms
LVEF less than or equal to 35%
VT of transient or reversible causes
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