Clinical trial NCT00836589: Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
Official title: GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Indicated for an ICD
Keywords: Long-term safety and reliability of ICD leads
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-04
Enrollment: 1997
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.

Brief summary: The objective of this study is to confirm the long-term safety and reliability of the Linox Lead System as used with BIOTRONIK ICDs. The GALAXY registry will provide data to fully characterize ICD lead failures, from implant through 5 years, including those failures contributing to patients losing pacing or defibrillation therapy.

Detailed description: This study is a multi-center, prospective, non-randomized, 5-year data collection registry. Eligible patients must have been successfully implanted with a Linox Lead System connected to a BIOTRONIK ICD and consented and enrolled between 1-45 days following implant. This study is designed to be a post-implant (office-based) registry, and patients are meant to be seen according to each institution's standard of care, but not to exceed a follow-up time frame of every 6 months. At least 2000 patients will be enrolled in this registry, and each patient will be followed for five years post-implant.

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.

Eligibility criteria: Inclusion Criteria:

* Successfully implanted Linox Lead System connected to a BIOTRONIK ICD, from 1-45 days prior to enrollment
* 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:

* Enrolled in any IDE clinical study
* 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

Primary outcomes:
measure: Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead
timeFrame: 5 years
measure: Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
timeFrame: 5 years
Secondary outcomes:
measure: Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (ICD, Device, and Implant Procedure Related) Through 5 Years Post-Implant.
timeFrame: 5 years
measure: Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.
timeFrame: 5 years
measure: Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
timeFrame: 5 years
measure: Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
timeFrame: 5 years
measure: Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
timeFrame: 5 years
measure: Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.
timeFrame: 5 years
measure: Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.
timeFrame: 5 years
measure: Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.
timeFrame: 5 years
Other outcomes:
Locations:
city: Albertville
country: United States
state: Alabama
city: Birmingham
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state: Alabama
city: Gadsden
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state: Alabama
city: Jasper
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state: Alabama
city: Glendale
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state: Arizona
city: Mesa
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state: Arizona
city: Phoenix
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state: Arizona
city: Scottsdale
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state: Arizona
city: Tucson
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state: Arizona
city: Burbank
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state: California
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state: California
city: Fountain Valley
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state: California
city: Glendale
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state: California
city: Hawthorne
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state: California
city: Inglewood
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state: California
city: Los Angeles
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state: California
city: Mission Viejo
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city: Northridge
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state: California
city: Rancho Mirage
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state: California
city: Santa Barbara
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city: Santa Maria
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city: Torrance
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state: California
city: Aurora
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state: Colorado
city: Boulder
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state: Colorado
city: Brooksville
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city: Daytona Beach
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city: Inverness
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city: Jacksonville
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city: Melbourne
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state: Florida
city: Miami
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city: Naples
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state: Florida
city: New Smyrna Beach
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state: Florida
city: Pensacola
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state: Florida
city: Port Charlotte
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state: Florida
city: Atlanta
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state: Georgia
city: Alton
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state: Illinois
city: Centralia
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state: Illinois
city: Chicago
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state: Illinois
city: Hammond
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state: Indiana
city: Jeffersonville
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state: Indiana
city: Owensboro
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state: Kentucky
city: Lafayette
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state: Louisiana
city: Lake Charles
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state: Louisiana
city: Marrero
country: United States
state: Louisiana
city: Baltimore
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state: Maryland
city: Cumberland
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state: Maryland
city: Rockville
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state: Maryland
city: Salisbury
country: United States
state: Maryland
city: Grand Rapids
country: United States
state: Michigan
city: Ypsilanti
country: United States
state: Michigan
city: Biloxi
country: United States
state: Mississippi
city: Bridgeton
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state: Missouri
city: Crystal City
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state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Haddon Heights
country: United States
state: New Jersey
city: Rochester
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state: New York
city: Charlotte
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state: North Carolina
city: Concord
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state: North Carolina
city: Gastonia
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state: North Carolina
city: Greensboro
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state: North Carolina
city: Grand Forks
country: United States
state: North Dakota
city: Columbus
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state: Ohio
city: Massillon
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state: Ohio
city: Toledo
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state: Ohio
city: Zanesville
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state: Ohio
city: Salem
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state: Oregon
city: Tualatin
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state: Oregon
city: Chinchilla
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state: Pennsylvania
city: Phoenixville
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state: Pennsylvania
city: Yardley
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state: Pennsylvania
city: Columbia
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state: South Carolina
city: Florence
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state: South Carolina
city: Greenville
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state: South Carolina
city: Greenwood
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state: South Carolina
city: Lancaster
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state: South Carolina
city: Rock Hill
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state: South Carolina
city: Chattanooga
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state: Tennessee
city: Amarillo
country: United States
state: Texas
city: El Paso
country: United States
state: Texas
city: Fort Worth
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Kingwood
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Yakima
country: United States
state: Washington
Study officials:
References:
citation: 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.