INGEVITY(TM) Active Fixation and Passive Fixation Pace/ Sense Lead Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,060
- 试验地点
- 155
- 主要终点
- Effectiveness 1
研究概览
简要总结
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads.
详细描述
The objective of this study is to gather data to establish the safety, performance and effectiveness of the INGEVITY pace/ sense leads
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
- •Subject is willing and capable of providing informed consent
- •Subject has a Class I or II indication for implantation of a single(VVI (R) only) or dual chamber pacemaker or a CRT-P system according to the ACC/AHA/HRS, or ESC guidelines
- •Subject is 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
- •Subject is age 18 or above, or of legal age to give informed consent specific to state and national law
排除标准
- •Subject has or has had any pacing or ICD system implants
- •Subject has a sensitivity to dexamethasone acetate (DXA)
- •Subject has a mechanical tricuspid heart valve
- •Subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries
- •Subjects with documented permanent or persistent AF where the physician intends to implant dual chamber pulse generator (single chamber VVIR pulse generators in these subjects is acceptable)
- •Subject is currently on the active heart transplant list
- •Subject has documented life expectancy of less than 12 months
- •Women of childbearing potential who are or might be pregnant at the time of study enrollment or INGEVITY Lead implant
- •Subjects currently requiring dialysis
结局指标
主要结局
Effectiveness 1
时间窗: Lead implant through 3 month follow up
The bipolar pacing threshold at 0.5 ms at three months post-implant \< 1.5 V
Effectiveness 2(Right Atrium)
时间窗: Lead implant through 3 month follow up
P-wave sensed amplitude at three months post-implant \> 1.5 mV
Safety 1 - Percentage of Leads Free From Complication (0 - 3 Months)
时间窗: Lead implant through 3 month follow up
Lead-related complication-free rate from lead implant through the three month follow-up, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 91.4%
Safety 3 - Hazard Rate of Lead-Related Complications
时间窗: Implant through 12 months (including available data beyond 12 months)
Hazard rate of lead-related complications over time. This endpoint will use the Weibull distribution to estimate the hazard over time by evaluating the Weibull shape parameter. A Weibull shape greater than one (\>1), equal to one (=1) and less than one (\<1) indicates accelerating, constant, and decelerating hazard of lead-related complications over time, respectively. This endpoint requires the Weibull shape estimate to be less than 1.
Safety 2 - Percentage of Leads Free From Complication (3 - 24 Months)
时间窗: 3 months through 12 months post implant
Lead-related complication-free rate from three months post-implant through twelve months post implant, based on complications that are related to the INGEVITY Lead. The performance goal based on similar leads was set in collaboration with FDA at 94%.
Effectiveness 2(Right Ventricle)
时间窗: Lead implant through 3 month follow up
R-wave sensed amplitude at three months post-implant \> 5 mV
Effectiveness 3
时间窗: Lead implant through 3 month follow up
Clinically acceptable pacing impedance between 300 Ω and 1300 Ω
次要结局
未报告次要终点