NCT01836497已完成不适用
SD01 Master Study (Safety and Efficacy Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 14
- 主要终点
- Serious adverse device effects (SADEs) related to the SD01 lead
研究概览
简要总结
The study is designed to confirm safety and efficacy of the SD01 ICD (implantable cardioverter-defibrillator) lead.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Standard indication for an ICD/CRT-D therapy
- •Signed informed consent form
- •Patient is willing and able to participate for the whole study duration
- •Patient is willing and able to activate and use the CardioMessenger
- •Legal capacity and ability to consent.
排除标准
- •Standard contraindication for an ICD/CRT-D therapy
- •Age <18 years.
- •Pregnant or breastfeeding
- •Cardiac surgery is planned within the next six months
- •Any condition that in the opinion of the investigator would preclude compliance with the study protocol during the whole follow-up period
- •Enrollment in another cardiac clinical investigation with active treatment arm
- •Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
- •Dexamethasone acetate intolerance
结局指标
主要结局
Serious adverse device effects (SADEs) related to the SD01 lead
时间窗: until the 3-month follow-up
Rate of appropriate sensing and pacing
时间窗: at the 3-month follow-up
The evaluation of right ventricular sensing performance is based on the assessment of consecutive intrinsic beats documented with markers on an IEGM (intra-cardiac electrogram). The evaluation of ventricular sensing performance is based on the data to be collected during the 3-month follow-up. The appropriate pacing performance in the right ventricle results from the evaluation of "capture" at the end of the 3-month follow-up.
次要结局
- Comparison of pacing threshold between Linoxsmart and SD01(at the 3-month follow-up)
- Shift rate of the painless shock impedance measurement(between 3- and 6-month follow-up)
研究者
研究点 (14)
Loading locations...
相似试验
已完成
不适用
TD01 Master Study (Safety and Efficacy Study)ICD/CRT-D IndicationNCT02087189Biotronik SE & Co. KG30
已完成
不适用
S-ICD® System Post Approval StudyPrimary Prevention of Sudden Cardiac ArrestSecondary Prevention of Sudden Cardiac ArrestNCT01736618Boston Scientific Corporation1,766
进行中（未招募）
1 期
Dose-Escalation Study of SCD-101 in Sickle Cell DiseaseSickle-Beta Zero ThalassemiaSickle Cell DiseaseNCT02380079Invenux, LLC60
终止
不适用
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the ElderlyCongestive Heart FailureCoronary Artery DiseaseCardiomyopathyMyocardial InfarctionNCT02121158VA Office of Research and Development167
已完成
不适用
Septal - Success Rate and Clinical Outcome of Septal Implant of Ventricular Defibrillation LeadVentricular FibrillationVentricular TachycardiaNCT00180297Boston Scientific Corporation215