OVATIO CRT and SITUS OTW LV Lead Post Approval Study

ELA Medical

Status: Completed

Conditions: Heart Failure

Study type: Observational

Funder types: Industry

Identifiers

NCT00795873

ITAC07

Details and patient eligibility

About

Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.

Enrollment: 2,260 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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