Status:
COMPLETED
OVATIO CRT and SITUS OTW LV Lead Post Approval Study
Lead Sponsor:
ELA Medical, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief Summary
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.
Eligibility Criteria
Inclusion
- NYHA Class III/IV
- Stable medical regimen
- QRS greater than or equal to 130 ms
- LVEF less than or equal to 35%
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2260 Patients enrolled
Trial Details
Trial ID
NCT00795873
Start Date
December 1 2008
Last Update
September 18 2013
Active Locations (33)
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1
Advanced Cardiac Specialists
Mesa, Arizona, United States, 85201
2
Southwest Cardiovascular Associates
Mesa, Arizona, United States, 85205
3
Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85206
4
Cardiovascular Medical Group of Southern California
Beverly Hills, California, United States, 90210