Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2260 participants
OBSERVATIONAL
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Stable medical regimen
* QRS greater than or equal to 130 ms
* LVEF less than or equal to 35%
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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ELA Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Divagno Cardiology
Rochelle Park, New Jersey, United States
The Heartcare Center
Saddle Brook, New Jersey, United States
Clinical Cardiovascular Specialists
Columbus, Ohio, United States
Toledo Clinic Inc.
Toledo, Ohio, United States
Cardiovascular Consultants, Inc.
Tulsa, Oklahoma, United States
Cardiac Consultants, PC
Lancaster, Pennsylvania, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, United States
Midlands Cardiology Associates
Columbia, South Carolina, United States
Countries
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Other Identifiers
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ITAC07
Identifier Type: -
Identifier Source: org_study_id