OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Completed

• 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

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2008-12
• Status Verified: 2012-03
• Last Update Submitted: 2013-09-16
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2260

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

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)

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

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