OVATIO CRT and SITUS OTW LV Lead Post Approval Study
- Conditions
- Heart Failure
- Registration Number
- NCT00795873
- Lead Sponsor
- ELA Medical, Inc.
- Brief Summary
Post approval study measuring safety outcomes on the Ovatio CRT-D and SITUS OTW LV lead over 5 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2260
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method SITUS OTW LV lead complication free rate 5 years
- Secondary Outcome Measures
Name Time Method System complication free rate 6 months
Trial Locations
- Locations (33)
Walter Kerwin, M.D., AMC
🇺🇸Los Angeles, California, United States
Southwest Cardiovascular Associates
🇺🇸Mesa, Arizona, United States
Advanced Cardiac Specialists
🇺🇸Mesa, Arizona, United States
Cardiovascular Associates of Mesa
🇺🇸Mesa, Arizona, United States
Pacific Arrhythmia Service
🇺🇸La Mesa, California, United States
Cardiovascular Medical Group of Southern California
🇺🇸Beverly Hills, California, United States
Center of Interventional Cardiology
🇺🇸Encino, California, United States
Payam Robert Yashar, M.D. Inc.
🇺🇸Los Angeles, California, United States
Valley Regional Arrhythmia Center
🇺🇸Tarzana, California, United States
Delaware Cardiovascular Associates
🇺🇸Wilmington, Delaware, United States
Florida Institute for Cardiovascular Care
🇺🇸Hollywood, Florida, United States
Electrophysiology Consultants of Florida
🇺🇸Miami Beach, Florida, United States
Primary Care Cardiology Research
🇺🇸Ayer, Massachusetts, United States
Internal Medicine & Cardiology Associates of SE New England, PC
🇺🇸Fall River, Massachusetts, United States
Oschner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Atul Prakash, M.D.
🇺🇸Clifton, New Jersey, United States
Cross County Cardiology
🇺🇸Edgewater, New Jersey, United States
Jackson Cardiology Associates, P.A.
🇺🇸Jackson, Mississippi, United States
High Desert Heart Institute Medical Corp.
🇺🇸Victorville, California, United States
Cardiovascular Associates of Mountainside, PA
🇺🇸Mountainside, New Jersey, United States
Joaquim J Correia, MD LLC
🇺🇸Newark, New Jersey, United States
Toledo Clinic Inc.
🇺🇸Toledo, Ohio, United States
Clinical Cardiovascular Specialists
🇺🇸Columbus, Ohio, United States
Divagno Cardiology
🇺🇸Rochelle Park, New Jersey, United States
Cardiovascular Consultants, Inc.
🇺🇸Tulsa, Oklahoma, United States
Midlands Cardiology Associates
🇺🇸Columbia, South Carolina, United States
Drexel University College of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Central Gerogia Heart Clinic
🇺🇸Macon, Georgia, United States
Cardiac Consultants, PC
🇺🇸Lancaster, Pennsylvania, United States
Clipper Cardiovascular Associates
🇺🇸Newburyport, Massachusetts, United States
NJ Heart
🇺🇸Newark, New Jersey, United States
Hudson Heart Group, PC
🇺🇸Guttenberg, New Jersey, United States
The Heartcare Center
🇺🇸Saddle Brook, New Jersey, United States