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

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ClinicalTrials.gov Identifier: NCT00836589
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Biotronik, Inc.

Tracking Information
First Submitted Date February 2, 2009
First Posted Date February 4, 2009
Results First Submitted Date December 18, 2017
Results First Posted Date February 15, 2019
Last Update Posted Date February 15, 2019
Study Start Date December 2008
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2018)
  • Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead [ Time Frame: 5 years ]
    The overall incidence of complications (serious adverse events that require additional invasive intervention to resolve or specific non-invasive actions) related to the Linox ICD leads implanted with a market-released BIOTRONIK ICD device was evaluated. This was evaluated as a serious adverse event free-rate (SAEFR).
  • Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type [ Time Frame: 5 years ]
    Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: September 28, 2018)
  • 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. [ Time Frame: 5 years ]
  • Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant. [ Time Frame: 5 years ]
  • Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. [ Time Frame: 5 years ]
    Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold is calculated as a mean across all study visits.
  • Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. [ Time Frame: 5 years ]
    The mean sensing measurement is calculated as a mean across all study visits.
  • Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant. [ Time Frame: 5 years ]
    The mean pacing impedance measurement is calculated as a mean across all study visits.
  • Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model. [ Time Frame: 5 years ]
    Pacing thresholds performed at 0.5 ms pulse-width were requested. Threshold data reported below was collected at 0.5 ms pulse-width. The mean pacing threshold of each Linox Lead System model was calculated as a mean across all study visits.
  • Individual Electrical Parameters (Sensing) of Each Linox Lead System Model. [ Time Frame: 5 years ]
    The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.
  • Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model. [ Time Frame: 5 years ]
    The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Patients Indicated for an ICD
Intervention Device: ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
Study Groups/Cohorts Data Collection Group
Intervention: Device: ICD Therapy - ICD Lead Registry
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 5, 2017)
1997
Original Estimated Enrollment
 (submitted: February 2, 2009)
2000
Actual Study Completion Date December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00836589
Other Study ID Numbers GALAXY
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Biotronik, Inc.
Study Sponsor Biotronik, Inc.
Collaborators Not Provided
Investigators Not Provided
PRS Account Biotronik, Inc.
Verification Date September 2018