Patients Indicated for an ICDGALAXYNCT00836589
Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
An observational study of Patients Indicated for an ICD, run by Biotronik, Inc. at 85 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Indicated for an ICD
- What is being tested?
- ICD Therapy - ICD Lead Registry
- Type of treatment
- Medical device
- How many people
- 1,997 participants
- Where
- 85 sitesUnited States
- Study dates
- Dec 2008to Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
85 sites in 1 country.
85 sites in 1 country
United States85 sites
Study site
Albertville, Alabama
Study site
Alton, Illinois
Study site
Amarillo, Texas
Study site
Atlanta, Georgia
Study site
Aurora, Colorado
Study site
Baltimore, Maryland
Study site
Biloxi, Mississippi
Study site
Birmingham, Alabama
Study site
Boulder, Colorado
Study site
Bridgeton, Missouri
Study site
Brooksville, Florida
Study site
Burbank, California
Study site
Centralia, Illinois
Study site
Charlotte, North Carolina
Study site
Chattanooga, Tennessee
Study site
Chicago, Illinois
Study site
Chinchilla, Pennsylvania
Study site
Columbia, South Carolina
Study site
Columbus, Ohio
Study site
Concord, North Carolina
Study site
Crystal City, Missouri
Study site
Cumberland, Maryland
Study site
Daytona Beach, Florida
Study site
El Paso, Texas
Study site
Fairfield, California
Study site
Florence, South Carolina
Study site
Fort Worth, Texas
Study site
Fountain Valley, California
Study site
Gadsden, Alabama
Study site
Gastonia, North Carolina
Study site
Glendale, Arizona
Study site
Glendale, California
Study site
Grand Forks, North Dakota
Study site
Grand Rapids, Michigan
Study site
Greensboro, North Carolina
Study site
Greenville, South Carolina
Study site
Greenwood, South Carolina
Study site
Haddon Heights, New Jersey
Study site
Hammond, Indiana
Study site
Hawthorne, California
Study site
Houston, Texas
Study site
Inglewood, California
Study site
Inverness, Florida
Study site
Jacksonville, Florida
Study site
Jasper, Alabama
Study site
Jeffersonville, Indiana
Study site
Kingwood, Texas
Study site
Lafayette, Louisiana
Study site
Lake Charles, Louisiana
Study site
Lancaster, South Carolina
Study site
Los Angeles, California
Study site
Marrero, Louisiana
Study site
Massillon, Ohio
Study site
McAllen, Texas
Study site
McKinney, Texas
Study site
Melbourne, Florida
Study site
Mesa, Arizona
Study site
Miami, Florida
Study site
Mission Viejo, California
Study site
Naples, Florida
Study site
New Smyrna Beach, Florida
Study site
Northridge, California
Study site
Owensboro, Kentucky
Study site
Pensacola, Florida
Study site
Phoenix, Arizona
Study site
Phoenixville, Pennsylvania
Study site
Port Charlotte, Florida
Study site
Rancho Mirage, California
Study site
Rochester, New York
Study site
Rock Hill, South Carolina
Study site
Rockville, Maryland
Study site
Salem, Oregon
Study site
Salisbury, Maryland
Study site
Santa Barbara, California
Study site
Santa Maria, California
Study site
Scottsdale, Arizona
Study site
St Louis, Missouri
Study site
Toledo, Ohio
Study site
Torrance, California
Study site
Tualatin, Oregon
Study site
Tucson, Arizona
Study site
Yakima, Washington
Study site
Yardley, Pennsylvania
Study site
Ypsilanti, Michigan
Study site
Zanesville, Ohio
About this study
Official title: 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.
Read the 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.
- Conditions
- Patients Indicated for an ICD
- Being tested
- ICD Therapy - ICD Lead Registry
- Keywords
- Long-term safety and reliability of ICD leads
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD Therapy - ICD Lead RegistryDevice
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
| Study group | Role | What they receive |
|---|---|---|
| Data Collection Group | Not described Receives: Device: ICD Therapy - ICD Lead Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 5 years
Secondary outcomes (8)
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.
Measured: 5 years
Number of Subjects Who Experienced Serious Adverse Event(s) Excluded From Primary Outcome 1 (RA Lead Related) Through 5 Years Post-Implant.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startDec 2008
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Indicated for an ICDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836589
- Sponsor's protocol ID
- GALAXY
- Acronym
- GALAXY
- Status last verified
- Sep 2018
- First submitted
- 2 Feb 2009
- Last updated
- 15 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 26990515
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry
- ClinicalTrials.gov ID
- NCT00836589
- Acronym / sponsor ID
- GALAXY / GALAXY
- Conditions
- Patients Indicated for an ICD
- Keywords
- Long-term safety and reliability of ICD leads
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,997 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 15 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Data Collection Group | – | Device: ICD Therapy - ICD Lead Registry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICD Therapy - ICD Lead RegistryCollecting long-term safety and efficacy data on a family of market-released ICD leads. | Device | Data Collection Group |
Primary outcome
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.
8 secondary outcomes
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
Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
Time frame: 5 years
Pacing Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.
Time frame: 5 years
Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.
Time frame: 5 years
Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.
Time frame: 5 years
Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.
Time frame: 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26990515Good 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
85 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Indicated for an ICD, run by Biotronik, Inc. at 85 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00836589, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.