Heart Failure Clinical Trial

OVATIO CRT and SITUS OTW LV Lead Post Approval Study

Summary

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

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

2260

Study ID:

NCT00795873

Recruitment Status:

Completed

Sponsor:

ELA Medical, Inc.

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There are 32 Locations for this study

See Locations Near You

Advanced Cardiac Specialists
Mesa Arizona, 85201, United States
Southwest Cardiovascular Associates
Mesa Arizona, 85205, United States
Cardiovascular Associates of Mesa
Mesa Arizona, 85206, United States
Cardiovascular Medical Group of Southern California
Beverly Hills California, 90210, United States
Center of Interventional Cardiology
Encino California, 91436, United States
Pacific Arrhythmia Service
La Mesa California, 91942, United States
Walter Kerwin, M.D., AMC
Los Angeles California, 90048, United States
Payam Robert Yashar, M.D. Inc.
Los Angeles California, 90067, United States
Valley Regional Arrhythmia Center
Tarzana California, 91356, United States
High Desert Heart Institute Medical Corp.
Victorville California, 92395, United States
Delaware Cardiovascular Associates
Wilmington Delaware, 19958, United States
Florida Institute for Cardiovascular Care
Hollywood Florida, 33021, United States
Electrophysiology Consultants of Florida
Miami Beach Florida, 33140, United States
Central Gerogia Heart Clinic
Macon Georgia, 31201, United States
Oschner Clinic Foundation
New Orleans Louisiana, 70121, United States
Primary Care Cardiology Research
Ayer Massachusetts, 01432, United States
Internal Medicine & Cardiology Associates of SE New England, PC
Fall River Massachusetts, 02720, United States
Clipper Cardiovascular Associates
Newburyport Massachusetts, 01950, United States
Jackson Cardiology Associates, P.A.
Jackson Mississippi, 39216, United States
Atul Prakash, M.D.
Clifton New Jersey, 07012, United States
Cross County Cardiology
Edgewater New Jersey, 07020, United States
Hudson Heart Group, PC
Guttenberg New Jersey, 07093, United States
Cardiovascular Associates of Mountainside, PA
Mountainside New Jersey, 07092, United States
Joaquim J Correia, MD LLC
Newark New Jersey, 07105, United States
NJ Heart
Newark New Jersey, 07105, United States
Divagno Cardiology
Rochelle Park New Jersey, 07662, United States
The Heartcare Center
Saddle Brook New Jersey, 07663, United States
Clinical Cardiovascular Specialists
Columbus Ohio, 43214, United States
Toledo Clinic Inc.
Toledo Ohio, 43623, United States
Cardiovascular Consultants, Inc.
Tulsa Oklahoma, 74136, United States
Cardiac Consultants, PC
Lancaster Pennsylvania, 17604, United States
Drexel University College of Medicine
Philadelphia Pennsylvania, 19102, United States
Midlands Cardiology Associates
Columbia South Carolina, 29223, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2260

Study ID:

NCT00795873

Recruitment Status:

Completed

Sponsor:


ELA Medical, Inc.

How clear is this clinincal trial information?

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