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

Study Overview

• Status: Completed
• Conditions: Patients Indicated for an ICD
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 1997

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Albertville, Alabama, United States
    • Birmingham, Alabama, United States
    • Gadsden, Alabama, United States
    • Jasper, Alabama, United States
  • Arizona
    • Glendale, Arizona, United States
    • Mesa, Arizona, United States
    • Phoenix, Arizona, United States
    • Scottsdale, Arizona, United States
    • Tucson, Arizona, United States
  • California
    • Burbank, California, United States
    • Fairfield, California, United States
    • Fountain Valley, California, United States
    • Glendale, California, United States
    • Hawthorne, California, United States
    • Inglewood, California, United States
    • Los Angeles, California, United States
    • Mission Viejo, California, United States
    • Northridge, California, United States
    • Rancho Mirage, California, United States
    • Santa Barbara, California, United States
    • Santa Maria, California, United States
    • Torrance, California, United States
  • Colorado
    • Aurora, Colorado, United States
    • Boulder, Colorado, United States
  • Florida
    • Brooksville, Florida, United States
    • Daytona Beach, Florida, United States
    • Inverness, Florida, United States
    • Jacksonville, Florida, United States
    • Melbourne, Florida, United States
    • Miami, Florida, United States
    • Naples, Florida, United States
    • New Smyrna Beach, Florida, United States
    • Pensacola, Florida, United States
    • Port Charlotte, Florida, United States
  • Georgia
    • Atlanta, Georgia, United States
  • Illinois
    • Alton, Illinois, United States
    • Centralia, Illinois, United States
    • Chicago, Illinois, United States
  • Indiana
    • Hammond, Indiana, United States
    • Jeffersonville, Indiana, United States
  • Kentucky
    • Owensboro, Kentucky, United States
  • Louisiana
    • Lafayette, Louisiana, United States
    • Lake Charles, Louisiana, United States
    • Marrero, Louisiana, United States
  • Maryland
    • Baltimore, Maryland, United States
    • Cumberland, Maryland, United States
    • Rockville, Maryland, United States
    • Salisbury, Maryland, United States
  • Michigan
    • Grand Rapids, Michigan, United States
    • Ypsilanti, Michigan, United States
  • Mississippi
    • Biloxi, Mississippi, United States
  • Missouri
    • Bridgeton, Missouri, United States
    • Crystal City, Missouri, United States
    • Saint Louis, Missouri, United States
  • New Jersey
    • Haddon Heights, New Jersey, United States
  • New York
    • Rochester, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • Concord, North Carolina, United States
    • Gastonia, North Carolina, United States
    • Greensboro, North Carolina, United States
  • North Dakota
    • Grand Forks, North Dakota, United States
  • Ohio
    • Columbus, Ohio, United States
    • Massillon, Ohio, United States
    • Toledo, Ohio, United States
    • Zanesville, Ohio, United States
  • Oregon
    • Salem, Oregon, United States
    • Tualatin, Oregon, United States
  • Pennsylvania
    • Chinchilla, Pennsylvania, United States
    • Phoenixville, Pennsylvania, United States
    • Yardley, Pennsylvania, United States
  • South Carolina
    • Columbia, South Carolina, United States
    • Florence, South Carolina, United States
    • Greenville, South Carolina, United States
    • Greenwood, South Carolina, United States
    • Lancaster, South Carolina, United States
    • Rock Hill, South Carolina, United States
  • Tennessee
    • Chattanooga, Tennessee, United States
  • Texas
    • Amarillo, Texas, United States
    • El Paso, Texas, United States
    • Fort Worth, Texas, United States
    • Houston, Texas, United States
    • Kingwood, Texas, United States
    • McAllen, Texas, United States
    • McKinney, Texas, United States
  • Washington
    • Yakima, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead	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).	5 years
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type	Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.		5 years
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.		5 years
Pacing Threshold Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.	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.	5 years
Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.	The mean sensing measurement is calculated as a mean across all study visits.	5 years
Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.	The mean pacing impedance measurement is calculated as a mean across all study visits.	5 years
Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.	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.	5 years
Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.	The mean sensing measurements of each Linox Lead System model were calculated as a mean across all study visits.	5 years
Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.	The mean pacing impedance of each Linox Lead System model was calculated as a mean across all study visits.	5 years

Collaborators and Investigators

• Sponsor: Biotronik, Inc.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: February 2, 2009
• First Submitted That Met QC Criteria: February 2, 2009
• First Posted (Estimate): February 4, 2009

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Long-term safety and reliability of ICD leads
• Other Study ID Numbers: GALAXY