Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
NCT ID: NCT00810264
Last Updated: 2019-11-29
Study Results
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View full resultsBasic Information
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COMPLETED
2499 participants
OBSERVATIONAL
2008-12-31
2018-11-02
Brief Summary
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Detailed Description
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Safety will be evaluated based on the analysis of the overall incidence of lead-related adverse events that require additional invasive intervention. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. Reporting of all adverse events will be performed twice a year in order to identify and characterize any trends in adverse events, failure modes, or failure rates.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Data Collection Group
CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
Interventions
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CRT Therapy - LV Lead Registry
Collecting long-term safety and efficacy data on a market-released left ventricular lead.
Eligibility Criteria
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Inclusion Criteria
* Able to understand the nature of the registry and give informed consent
* Available for follow-up visits on a regular basis at the investigational site
* Age greater than or equal to 18 years
Exclusion Criteria
* Planned cardiac surgical procedures or interventional measures within the next 6 months
* Expected to receive a heart transplant within 1 year
* Life expectancy less than 1 year
* Presence of another life-threatening, underlying illness separate from their cardiac disorder
* Pregnancy
* Inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
18 Years
ALL
No
Sponsors
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Biotronik, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Anaheim, California, United States
Fairfield, California, United States
Fountain Valley, California, United States
Glendale, California, United States
Hawthorne, California, United States
Inglewood, California, United States
Los Angeles, California, United States
National City, California, United States
Northridge, California, United States
Orange, California, United States
Rancho Mirage, California, United States
Santa Barbara, California, United States
Torrance, California, United States
Ventura, California, United States
Watsonville, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Danbury, Connecticut, United States
Brooksville, Florida, United States
Davenport, Florida, United States
Melbourne, Florida, United States
Naples, Florida, United States
New Smyrna Beach, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Macon, Georgia, United States
Urbana, Illinois, United States
Fort Wayne, Indiana, United States
Valparaiso, Indiana, United States
Owensboro, Kentucky, United States
Covington, Louisiana, United States
Hammond, Louisiana, United States
Lafayette, Louisiana, United States
Bangor, Maine, United States
Baltimore, Maryland, United States
Cumberland, Maryland, United States
Lanham, Maryland, United States
Rockville, Maryland, United States
Burlington, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Lansing, Michigan, United States
Lapeer, Michigan, United States
Saginaw, Michigan, United States
Wyoming, Michigan, United States
Ypsilanti, Michigan, United States
Tupelo, Mississippi, United States
Crystal City, Missouri, United States
St Louis, Missouri, United States
Las Vegas, Nevada, United States
Glen Ridge, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Gastonia, North Carolina, United States
Winston-Salem, North Carolina, United States
Columbus, Ohio, United States
Middletown, Ohio, United States
Steubenville, Ohio, United States
Toledo, Ohio, United States
Oklahoma City, Oklahoma, United States
Salem, Oregon, United States
Chinchilla, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pottstown, Pennsylvania, United States
Yardley, Pennsylvania, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Spartanburg, South Carolina, United States
Chattanooga, Tennessee, United States
Amarillo, Texas, United States
Brownsville, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Kingwood, Texas, United States
McKinney, Texas, United States
Nacogdoches, Texas, United States
Fredericksburg, Virginia, United States
Spokane, Washington, United States
Yakima, Washington, United States
Countries
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References
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Good ED, Cakulev I, Orlov MV, Hirsh D, Simeles J, Mohr K, Moll P, Bloom H. Long-Term Evaluation of Biotronik Linox and Linox(smart) Implantable Cardioverter Defibrillator Leads. J Cardiovasc Electrophysiol. 2016 Jun;27(6):735-42. doi: 10.1111/jce.12971. Epub 2016 May 3.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CELESTIAL
Identifier Type: -
Identifier Source: org_study_id
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