Clinical Study to Evaluate System Safety and Clinical Performance of the SecuraTM ICD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 13
- 主要终点
- Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
研究概览
简要总结
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
详细描述
The Secura ICD is an investigational dual chamber ICD that provides atrial and ventricular tachyarrhythmia detection and therapy, cardioversion, defibrillation, dual chamber rate-responsive bradycardia pacing and diagnostics.
The study will be a prospective, non-randomized, multicenter clinical study, conducted in approximately 15 centers.
To allow for sufficient experience with the device, a maximum of 80 subjects may be implanted with the Secura device. Data will be collected at baseline (enrollment), implant, 1-, 3-, and 6- months post implant and every 6 months thereafter or until study closure (whichever occurs first), Unscheduled Follow-up visits, System Modifications, Technical Observations, Study Deviations, Study Exit, upon notification of new or updated Adverse Events and in case of death.
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
- •Patients who have an ICD indication.
- •Patients who are geographically stable and available for follow-up at the study center for the duration of the study.
- •Patients who have signed a Medical Ethics Committee (MEC) approved Informed Consent form.
排除标准
- •Patients with a life expectancy less than the duration of the study.
- •Patients with medical conditions that preclude the testing required for all patients by the study protocol or that otherwise limit study participation required for all patients.
- •Patients with mechanical tricuspid heart valves.
结局指标
主要结局
Freedom From Unanticipated Serious Adverse Device Effects at 1-month Post Implant.
时间窗: 1 month
Criteria to assess the results of the primary objective safety analysis is to demonstrate that the percentage of subjects experiencing an Unanticipated Serious Adverse Device Effect (USADE) is lower than 10% at one-month post-implant, with one month considered to be the same as 28 days. A pre-specified interim analysis is included in the study which, if the primary objective was met, is to also be considered the final analysis.
次要结局
- System Performance Assessed by Holter Records(1 month)
- System Performance Assessed by Save to Disk Files(1 month follow-up)
- Adverse Events(1 Month)
- System Performance Assessed by Technical Observations(1 month follow-up)