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
- 194
- 试验地点
- 26
- 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 S pacing lead when implanted in the left bundle branch (LBB) area. 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 Cardiac Resynchronization Therapy with a Pacemaker (CRT-P) systems are allowed.
- •Patient has an implant planned to utilize left bundle branch area 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 Implantable Cardioverter-Defibrillator (ICD) device
- •Patient has had a previous unsuccessful attempt to place a lead in the LBB area
- •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 S LBB lead
干预措施: Solia 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
The overall rate of serious Solia S Left Bundle Branch (LBB) lead related adverse device effects and serious implant procedure events related to the Solia S LBB lead that occur through 3 months post-implant. The definition of adverse device effect is an untoward medical occurrence (e.g. disease, injury) related to the use of a study device. Pacemaker lead-related examples include events such as lead dislodgements or lead malfunction. The Solia S LBB lead complication-free rate is calculated as the number of subjects without one or more adverse device effect complications divided by the total number of study subjects successfully enrolled and subjects undergoing an unsuccessful implant attempt who have a qualifying primary safety endpoint event. Classification of adverse device related events from the pool of potential events is determined by a clinical events committee (CEC). The complication-free rate is expressed in percent.
Implant Success Rate of the Solia S Lead in LBB Area
时间窗: at implant procedure
The percentage of subjects with Solia S placed successfully in the LBBA divided by the total number of consented study subjects in whom an implant of Solia S in the LBBA was attempted.
次要结局
- Quality of Life (QOL) From Baseline Through 12 Months Post-Implant(12 months post implant)
- Sensing Measurements for Solia S Lead at 3 Months(3 months post implant)
- Pacing Impedance for Solia S Lead at 3 Months(3 months post implant)
- Pacing Threshold Measurements for Solia S Lead at 6 Months(6 months post implant)
- Sensing Measurements for Solia S Lead at 6 Months(6 months post implant)
- Pacing Impedance for Solia S Lead at 6 Months(6 months post implant)
- Pacing Threshold Measurements for Solia S Lead at 12 Months(12 months post implant)
- Sensing Measurements for Solia S Lead at 12 Months(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 for Solia S Lead at 3 Months(3 months post implant)
- Pacing Impedance for Solia S Lead at 12 Months(12 months post implant)