Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | December 2008 |
End Date: | December 2016 |
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.
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.
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.
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
We found this trial at
85
sites
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