Long-term Evaluation of the Linox Family ICD Leads Registry (GALAXY)
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Purpose
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 | Intervention |
|---|---|
|
Patients Indicated for an ICD |
Device: ICD Therapy - ICD Lead Registry |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry |
| Estimated Enrollment: | 2000 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | February 2017 |
| Estimated Primary Completion Date: | February 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Data Collection Group |
Device: ICD Therapy - ICD Lead Registry
Collecting long-term safety and efficacy data on a family of market-released ICD leads.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients will be obtained from the investigators' general patient population according to the inclusion and exclusion criteria described below.
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
Contacts and Locations
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No publications provided
| Responsible Party: | Biotronik, Inc. |
| ClinicalTrials.gov Identifier: | NCT00836589 History of Changes |
| Other Study ID Numbers: | GALAXY |
| Study First Received: | February 2, 2009 |
| Last Updated: | May 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Biotronik, Inc.:
|
Long-term safety and reliability of ICD leads |
ClinicalTrials.gov processed this record on May 16, 2013