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Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.
ClinicalTrials.gov Identifier:
NCT00836589
First received: February 2, 2009
Last updated: May 13, 2014
Last verified: May 2014

February 2, 2009
May 13, 2014
December 2008
November 2016   (final data collection date for primary outcome measure)
Overall complication-free rate [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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Complete list of historical versions of study NCT00836589 on ClinicalTrials.gov Archive Site
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Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.

Patients Indicated for an ICD
Device: ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Data Collection Group
Intervention: Device: ICD Therapy - ICD Lead Registry
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
2000
November 2016
November 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00836589
GALAXY
No
Biotronik, Inc.
Biotronik, Inc.
Not Provided
Not Provided
Biotronik, Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP