INGEVITY+ Active Fixation Pace/Sense Lead Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 13
- 主要终点
- Primary Efficacy: Pacing Capture Threshold Responder Rate
研究概览
简要总结
The objective of this study is it to confirm the safety and effectiveness of the INGEVITY+ Active Fixation Pace/Sense Lead.
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
- •Subject is willing and capable of providing informed consent
- •Subject is intended to undergo initial (de novo) pacing system implant using INGEVITY+ Leads in the Right Atrium (RA) and Right Ventricle (RV) and a Boston Scientific pulse generator
- •Subject meets an indication for a Boston Scientific Pacemaker or CRT-P device per product labeling (Physician's Technical Manual)
- •Willing and capable of participating in all testing/visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol
- •Age 18 or above, or of legal age to give informed consent specific to state and national law
排除标准
- •Known or suspected sensitivity to dexamethasone acetate (DXA)
- •Has a mechanical tricuspid heart valve
- •Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY+ Lead implant (method of assessment upon physician's discretion)
- •Currently requiring hemo- or peritoneal dialysis
- •Subject has or has had implanted any pacing or ICD system, including subcutaneous, transvenous or leadless systems
- •Intended to receive a single chamber device
- •Documented history of permanent or persistent AF
- •Currently on an active organ transplant list
- •Documented life expectancy of less than 12 months
- •Enrolled in any other concurrent study unless prior approval is received from the Sponsor
结局指标
主要结局
Primary Efficacy: Pacing Capture Threshold Responder Rate
时间窗: At 3-Months Post-Implant
This endpoint evaluated the % of leads with an adequate INGEVITY+ Pacing Capture Threshold (PCT) measurement. A lead with an adequate INGEVITY+ PCT measurement was referred to as a Pacing Capture Threshold Responder. A responder was defined by a PCT at 3-month visit ≤ 2 V, measured at 0.4 ms pulse width. A performance goal of 80% was used.
Primary Safety: Lead-related Complication-Free Rate
时间窗: Lead Implant through 3-Months Post-Implant
This endpoint evaluated the percentage of leads free from complication from three months post-implant through twelve months post implant. The performance goal was 93%. Kaplan-Meier methodology was used to calculate the complication-free rate %.
次要结局
- Secondary Efficacy: Sensed Amplitude in mV (Right Atrial Leads)(At 3-Months Post-Implant)
- Secondary Efficacy: Sensed Amplitude in mV (Right Ventricular Leads)(At 3-Months Post-Implant)
- Secondary Efficacy: Pacing Impedance in Ohms(At 3-Months Post-Implant)