Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
NCT ID: NCT00836589
Last Updated: 2019-02-15
Study Results
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View full resultsBasic Information
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COMPLETED
1997 participants
OBSERVATIONAL
2008-12-31
2016-12-31
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 to resolve. In addition, each individual adverse event will be separately investigated. Lead parameters for sensing, pacing thresholds, and impedance will also be evaluated. An independent Clinical Events Committee will review and adjudicate all adverse events that occur during the study according to the protocol definitions.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Data Collection Group
ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Interventions
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ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Eligibility Criteria
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Inclusion Criteria
* Able to understand the nature of the registry and provide 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 investigational 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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Albertville, Alabama, United States
Birmingham, Alabama, United States
Gadsden, Alabama, United States
Jasper, Alabama, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Burbank, 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
Mission Viejo, California, United States
Northridge, California, United States
Rancho Mirage, California, United States
Santa Barbara, California, United States
Santa Maria, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Brooksville, Florida, United States
Daytona Beach, Florida, United States
Inverness, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
New Smyrna Beach, Florida, United States
Pensacola, Florida, United States
Port Charlotte, Florida, United States
Atlanta, Georgia, United States
Alton, Illinois, United States
Centralia, Illinois, United States
Chicago, Illinois, United States
Hammond, Indiana, United States
Jeffersonville, Indiana, United States
Owensboro, Kentucky, United States
Lafayette, Louisiana, United States
Lake Charles, Louisiana, United States
Marrero, Louisiana, United States
Baltimore, Maryland, United States
Cumberland, Maryland, United States
Rockville, Maryland, United States
Salisbury, Maryland, United States
Grand Rapids, Michigan, United States
Ypsilanti, Michigan, United States
Biloxi, Mississippi, United States
Bridgeton, Missouri, United States
Crystal City, Missouri, United States
St Louis, Missouri, United States
Haddon Heights, New Jersey, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Concord, North Carolina, United States
Gastonia, North Carolina, United States
Greensboro, North Carolina, United States
Grand Forks, North Dakota, United States
Columbus, Ohio, United States
Massillon, Ohio, United States
Toledo, Ohio, United States
Zanesville, Ohio, United States
Salem, Oregon, United States
Tualatin, Oregon, United States
Chinchilla, Pennsylvania, United States
Phoenixville, Pennsylvania, United States
Yardley, Pennsylvania, United States
Columbia, South Carolina, United States
Florence, South Carolina, United States
Greenville, South Carolina, United States
Greenwood, South Carolina, United States
Lancaster, South Carolina, United States
Rock Hill, South Carolina, United States
Chattanooga, Tennessee, United States
Amarillo, Texas, United States
El Paso, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Kingwood, Texas, United States
McAllen, Texas, United States
McKinney, Texas, 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.
Other Identifiers
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GALAXY
Identifier Type: -
Identifier Source: org_study_id
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