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

Study Overview
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Brief Summary
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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
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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.

Official Title
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GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry

Conditions
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Patients Indicated for an ICD

Intervention / Treatment
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* Device: ICD Therapy - ICD Lead Registry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Data Collection Group<br> | Device: ICD Therapy - ICD Lead Registry<br>* Collecting long-term safety and efficacy data on a family of market-released ICD leads.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long-term safety and reliability of ICD leads