OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Completed

Conditions studied: Heart Failure

In brief

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

Key facts

Study ID

NCT00795873

Run by

ELA Medical, Inc.

People needed

2260

Starts

2008-12-01

Last updated by the study team

2013-09-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• NYHA Class III/IV
• Stable medical regimen
• QRS greater than or equal to 130 ms
• LVEF less than or equal to 35%

You may not qualify if…

• 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

Where it is running

• Advanced Cardiac Specialists — Mesa, Arizona, United States
• Southwest Cardiovascular Associates — Mesa, Arizona, United States
• Cardiovascular Associates of Mesa — Mesa, Arizona, United States
• Cardiovascular Medical Group of Southern California — Beverly Hills, California, United States
• Center of Interventional Cardiology — Encino, California, United States
• Pacific Arrhythmia Service — La Mesa, California, United States
• Walter Kerwin, M.D., AMC — Los Angeles, California, United States
• Payam Robert Yashar, M.D. Inc. — Los Angeles, California, United States
• Valley Regional Arrhythmia Center — Tarzana, California, United States
• High Desert Heart Institute Medical Corp. — Victorville, 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
• Central Gerogia Heart Clinic — Macon, Georgia, United States
• Oschner Clinic Foundation — New Orleans, Louisiana, United States
• Primary Care Cardiology Research — Ayer, Massachusetts, United States
• Internal Medicine & Cardiology Associates of SE New England, PC — Fall River, Massachusetts, United States
• Clipper Cardiovascular Associates — Newburyport, Massachusetts, United States
• Jackson Cardiology Associates, P.A. — Jackson, Mississippi, United States
• Atul Prakash, M.D. — Clifton, New Jersey, United States
• Cross County Cardiology — Edgewater, New Jersey, United States
• Hudson Heart Group, PC — Guttenberg, New Jersey, United States
• Cardiovascular Associates of Mountainside, PA — Mountainside, New Jersey, United States
• Joaquim J Correia, MD LLC — Newark, New Jersey, United States
• NJ Heart — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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