Clinical trial NCT00810264: Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar
Official title: CELESTIAL Post Approval Registry: Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar Post Approval Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congestive Heart Failure
Keywords: Long-term safety and reliability of a bipolar left ventricular lead on congestive heart failure patients
Lead sponsor: Biotronik, Inc.
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 2499
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 Corox OTW BP left ventricular (LV) pacing lead. As a condition of approval, the FDA required that a registry documenting the post approval clinical experience of these leads be designed and implemented.

Detailed description: This study is an FDA-required, multi-center, prospective, non-randomized, data collection registry. Eligible patients must have been successfully implanted with a Corox OTW BP, Corox OTW-S BP, or Corox OTW-L BP LV lead with a BIOTRONIK CRT device and consented and enrolled between 7-180 days following implant. At least 2500 patients will be enrolled in this post-approval 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. 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.

Eligibility criteria: Inclusion Criteria:

* Successfully implanted BIOTRONIK CRT system, including a Corox BP LV lead, from 7-180 days prior to enrollment
* 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:

* Enrolled in any IDE clinical study
* 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

Primary outcomes:
measure: Percentage of Subjects Who Are Free of Complications Related to the Corox LV Lead
timeFrame: 5 years
measure: Percentage of Subjects Experiencing Individual Complications
timeFrame: 5 years
Secondary outcomes:
measure: Mean Successful Biventricular Pacing in Subjects at the 5 Year In-office Visit.
timeFrame: 5 years
measure: Percentage of Subjects Experiencing Serious Adverse Event Excluded From Primary Safety Endpoint
timeFrame: 5 years
measure: Corox BP LV Lead Pacing Threshold Measurements
timeFrame: 5 years
measure: Corox BP LV Lead Sensing Measurements
timeFrame: 5 years
measure: Corox BP LV Lead Impedance Measurements
timeFrame: 5 years
measure: Pacing Threshold Measurements Per Corox BP LV Lead Model
timeFrame: 5 years
measure: Sensing Measurements Per Corox BP LV Lead Model
timeFrame: 5 years
measure: Impedance Measurements Per Corox BP LV Lead Model
timeFrame: 5 years
measure: Overall Incidence of Primary Endpoint 1 Serious Adverse Events for Each Corox BP Lead Model
timeFrame: 5 years
measure: Incidence of Individual Types of Primary Endpoint 2 Adverse Events Will be Evaluated Separately for Each Corox BP Lead Model
timeFrame: 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
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: Anaheim
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state: California
city: Fairfield
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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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city: Inglewood
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state: California
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state: Colorado
city: Boulder
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state: Colorado
city: Danbury
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state: Connecticut
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city: Davenport
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city: Melbourne
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city: Naples
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city: New Smyrna Beach
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state: Florida
city: Saint Petersburg
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state: Florida
city: Tampa
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state: Florida
city: Macon
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state: Georgia
city: Urbana
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state: Illinois
city: Fort Wayne
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state: Indiana
city: Valparaiso
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state: Indiana
city: Owensboro
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state: Kentucky
city: Covington
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state: Louisiana
city: Hammond
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state: Louisiana
city: Lafayette
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state: Louisiana
city: Bangor
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state: Maine
city: Baltimore
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state: Maryland
city: Cumberland
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state: Maryland
city: Lanham
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state: Maryland
city: Rockville
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state: Maryland
city: Burlington
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state: Massachusetts
city: Worcester
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state: Massachusetts
city: Ann Arbor
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state: Michigan
city: Lansing
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state: Michigan
city: Lapeer
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state: Michigan
city: Saginaw
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state: Michigan
city: Wyoming
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state: Michigan
city: Ypsilanti
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state: Michigan
city: Tupelo
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state: Mississippi
city: Crystal City
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state: Missouri
city: Saint Louis
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state: Missouri
city: Las Vegas
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state: Nevada
city: Glen Ridge
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state: New Jersey
city: New York
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state: New York
city: Rochester
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state: New York
city: Gastonia
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Columbus
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state: Ohio
city: Middletown
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state: Ohio
city: Steubenville
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state: Ohio
city: Toledo
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state: Ohio
city: Oklahoma City
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city: Philadelphia
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state: Pennsylvania
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state: Pennsylvania
city: Columbia
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city: Greenville
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city: Spartanburg
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state: South Carolina
city: Chattanooga
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state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Brownsville
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state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Kingwood
country: United States
state: Texas
city: McKinney
country: United States
state: Texas
city: Nacogdoches
country: United States
state: Texas
city: Fredericksburg
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
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.