Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

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.

Condition or disease Intervention/treatment
Patients Indicated for an ICD Device: ICD Therapy - ICD Lead Registry

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1997 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry
Study Start Date : December 2008
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Group/Cohort Intervention/treatment
Data Collection Group Device: ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00836589


Locations
Show Show 85 study locations
Sponsors and Collaborators
Biotronik, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Biotronik, Inc.
ClinicalTrials.gov Identifier: NCT00836589    
Other Study ID Numbers: GALAXY
First Posted: February 4, 2009    Key Record Dates
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019
Last Verified: September 2018
Keywords provided by Biotronik, Inc.:
Long-term safety and reliability of ICD leads