Safety and Performance Study of the Siello S Pacing Lead
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1,758
- 主要终点
- Siello S Lead Effectiveness at 12 Months
研究概览
简要总结
The objective of the SIELLO study is to demonstrate the safety and effectiveness of the BIOTRONIK Siello S pacing lead.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Candidate for de novo implantation of a BIOTRONIK pacemaker system, including one or two Siello S leads. Candidate meets recommendation for pacemaker system implant put forth by guidelines of relevant professional societies.
- •Able to understand the nature of the study and provide informed consent.
- •Available for follow-up visits on a regular basis at the investigational site for the expected 5 years of follow-up.
- •Age greater than or equal to 18 years.
排除标准
- •Enrolled in any other investigational clinical study.
- •Currently implanted with a pacemaker or ICD device.
- •Planned cardiac surgical procedures or interventional 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.
- •Pregnant at the time of enrollment.
结局指标
主要结局
Siello S Lead Effectiveness at 12 Months
时间窗: 12-months
Success rate of the implanted system to sense and deliver pacing at 12-months post implant.
Ventricular Siello S Lead Safety at 5 Years
时间窗: 5-Years
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 5 years follow-up. This was evaluated as an adverse event free-rate (AEFR).
Atrial Siello S Lead Safety at 12 Months
时间窗: 12 month
The overall percentage subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the atrium with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Ventricular Siello S Lead Safety at 12 Months
时间窗: 12-month
The overall percentage of subjects with adverse events that require additional invasive intervention to resolve, related to the Siello leads implanted in the ventricle with a BIOTRONIK Evia pacemaker device through 12 months follow-up. This was evaluated as an adverse event free-rate (AEFR).
Ventricular Siello S Lead Safety at 5 Years - Individual Adverse Event Rates
时间窗: 5-years
Evaluation of the individual adverse events contributing to the outcome measure 'Ventricular Siello S Lead Safety at 5 Years'.
次要结局
- Atrial Siello S Lead Safety at 5 Years - Individual Adverse Event Rates(5-years)
- Atrial Siello S Lead Safety at 5 Years(5-years)
- Pacing Threshold Measurements for Siello S Leads Through 5 Years(5-years)
- Impedance Measurements for Siello S Leads Through 5 Years(5-years)
- Pacing Threshold Measurements for Siello S Leads at 12 Months(12-months)
- Sensing Measurements for Siello S Leads at 12 Months(12-months)
- Percentage of Participants With Other Adverse Events(5-years)
- Impedance Measurements for Siello S Leads at 12 Months(12-months)
- Siello S Lead Effectiveness at 5 Years(5-years)
- Sensing Measurements for Siello S Leads Through 5 Years(5-years)