RELIANCE 4-FRONT™ Active Fixation Defibrillation Lead Post Market Clinical Follow-Up (PMCF) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 29
- 主要终点
- Complication Free Rate
研究概览
简要总结
The objective of this study is to gather data to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT™ Active Fixation Defibrillation Leads.
详细描述
The RELIANCE 4-FRONT Defibrillation Lead Post Market Clinical Follow-Up Study is a prospective, non-randomized, multi-center, single-group, post market clinical study to establish the chronic safety, performance and effectiveness of the RELIANCE 4-FRONT active fixation defibrillation leads.
A total of 167 patients (including 10 % attrition) are required to evaluate the Primary Endpoint.
Up to 20 Investigational centers located in Europe and Asia Pacific. Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
Lead-related complications associated with the RELIANCE 4-FRONT active fixation lead will count toward this endpoint.
Lead-related Complication-Free Rate from 3 Months through 15 Months Post-Implant.
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
- •Willing and capable of providing informed consent
- •Has an indication for implantation of a single or dual chamber ICD or CRT-D system in their respective geography
- •Subjects planned to be implanted with the RELIANCE 4-FRONT Active Fixation Lead
- •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)
- •Mechanical tricuspid heart valve
- •Subject is enrolled in any other concurrent study without prior written approval from Boston Scientific (BSC), with the exception of local mandatory governmental registries and observational studies/registries that are not in conflict and do not affect the following:
- •Schedule of procedures for the RELIANCE 4-Front Study (i.e. should not cause additional or missed visits);
- •RELIANCE 4-Front Study outcome (i.e. involve medications that could affect the heart rate of the subject);
- •Conduct of the RELIANCE 4-Front Study per Good Clinical Practice (GCP)/ International Organization for Standardization (ISO) 14155:2011/ 21 CFR 812/ local regulations
- •Currently on the active heart transplant list
- •Documented life expectancy of less than 12 months
- •Women of childbearing potential who are or might be pregnant at the time of study enrollment (method of assessment upon physician discretion)
- •Currently requiring chronic dialysis
结局指标
主要结局
Complication Free Rate
时间窗: 3-months follow-up
Lead-related Complication-Free Rate (CFR) from Implant through 3 Months Post-Implant.
次要结局
- Complication Free Rate(3 months through 15 months post implant)