GALAXY Registry: Long-term Evaluation of the Linox Family ICD Leads Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,997
- 主要终点
- Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Number of Subjects Who Experienced Primary Outcome 1 Complication(s) Per Individual Complication Type
时间窗: 5 years
Evaluation of the individual types of serious adverse events (SAEs) contributing to primary outcome 1 and their associated SAE category.
Percentage of Subjects Who Are Free of Complications Related to the Linox ICD Lead
时间窗: 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).
次要结局
- Individual Electrical Parameters (Sensing) of Each Linox Lead System Model.(5 years)
- Individual Electrical Parameters (Pacing Impedance) of Each Linox Lead System Model.(5 years)
- 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)
- Sensing Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups 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.(5 years)
- Individual Electrical Parameters (Pacing Threshold) of Each Linox Lead System Model.(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 Impedance Measurements for the Linox Lead System at Scheduled GALAXY Registry Follow-ups Through 5 Years Post-implant.(5 years)