BIOTRONIK Conduction System Pacing With the Solia Lead
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 17
- 主要终点
- Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
研究概览
简要总结
The purpose of the BIO-CONDUCT study is to demonstrate the safety and effectiveness of the BIOTRONIK Solia CSP S pacing lead when implanted in the left bundle branch area (LBBA). Safety will be assessed by evaluating serious adverse device effects that occur through 3 months post-implant. Efficacy will be assessed by evaluating implant success rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient is a candidate for implantation of a BIOTRONIK pacemaker system, per standard guidelines. Single chamber, dual chamber, and CRT-P systems are allowed.
- •Patient has an implant planned to utilize left bundle branch area (LBBA) pacing within 30 days of consent
- •Patient is able to understand the nature of the study and provide written informed consent
- •Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
- •Patient accepts Home Monitoring® concept
- •Patient age is greater than or equal to 18 years at time of consent
排除标准
- •Patient meets a standard contraindication for pacemaker system implant
- •Patient is currently implanted with a pacemaker or ICD device
- •Patient has had a previous unsuccessful attempt to place a lead in the LBBA
- •Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
- •Patient is expected to receive a heart transplant within 12 months
- •Patient life expectancy less than 12 months
- •Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
- •Patient reports pregnancy at the time of enrollment
- •Patient is enrolled in any other investigational cardiac clinical study during the course of the study
研究组 & 干预措施
Solia CSP S LBB Lead
干预措施: Solia CSP S lead (Device)
结局指标
主要结局
Serious Adverse Device Effect (SADE)-Free Rate at 3 Months
时间窗: 3 months post-implant
Serious adverse device effect includes both serious lead related and serious implant related device effects. The overall percentage of subjects without serious lead related adverse device effects related to Solia CSP S lead utilized or attempted to be implanted in the LBBA and serious implant procedure events related to the Solia CSP S LBBA lead will be reported.
Implant Success Rate
时间窗: At implant procedure
The overall percentage of subjects with successful placement of Solia CSP S lead in LBBA will be reported.
次要结局
- Quality of Life (QOL) from Baseline through 12 Months Post-Implant(12 months post-implant)
- Serious Adverse Device Effect (SADE)-Free Rate at 6 Months(6 months post-implant)
- Serious Adverse Device Effect (SADE)-Free Rate at 12 Months(12 months post-implant)
- Pacing Threshold Measurements at 3 Months(3 months post-implant)
- Sensing Measurements at 3 Months(3 months post-implant)
- Pacing Impedance at 3 Months(3 months post-implant)
- Pacing Threshold Measurements at 6 Months(6 months post-implant)
- Sensing Measurements at 6 Months(6 months post-implant)
- Pacing Impedance at 6 Months(6 months post-implant)
- Pacing Threshold Measurements at 12 Months(12 months post-implant)
- Sensing Measurements at 12 Months(12 months post-implant)
- Pacing Impedance at 12 Months(12 months post-implant)