Heart Failure Clinical Trial
OVATIO CRT and SITUS OTW LV Lead Post Approval Study
Summary
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.
Eligibility Criteria
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
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There are 32 Locations for this study
Mesa Arizona, 85201, United States
Mesa Arizona, 85205, United States
Mesa Arizona, 85206, United States
Beverly Hills California, 90210, United States
Encino California, 91436, United States
La Mesa California, 91942, United States
Los Angeles California, 90048, United States
Los Angeles California, 90067, United States
Tarzana California, 91356, United States
Victorville California, 92395, United States
Wilmington Delaware, 19958, United States
Hollywood Florida, 33021, United States
Miami Beach Florida, 33140, United States
Macon Georgia, 31201, United States
New Orleans Louisiana, 70121, United States
Ayer Massachusetts, 01432, United States
Fall River Massachusetts, 02720, United States
Newburyport Massachusetts, 01950, United States
Jackson Mississippi, 39216, United States
Clifton New Jersey, 07012, United States
Edgewater New Jersey, 07020, United States
Guttenberg New Jersey, 07093, United States
Mountainside New Jersey, 07092, United States
Newark New Jersey, 07105, United States
Newark New Jersey, 07105, United States
Rochelle Park New Jersey, 07662, United States
Saddle Brook New Jersey, 07663, United States
Columbus Ohio, 43214, United States
Toledo Ohio, 43623, United States
Tulsa Oklahoma, 74136, United States
Lancaster Pennsylvania, 17604, United States
Philadelphia Pennsylvania, 19102, United States
Columbia South Carolina, 29223, United States
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