NCT06604169进行中（未招募）不适用
An Observational Study of Subcutaneous Implantable Cardioverter Defibrillator in Patients with Hypertrophic Cardiomyopathy At High Risk of Sudden Cardiac Death
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 589 人开始时间: 2024年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 589
- 试验地点
- 1
- 主要终点
- the failure rate of S-ICD screening
研究概览
简要总结
- To observe the failure rate of S-ICD screening in HCM patients at high risk of SCD.
- To observe the incidence of IAS in HCM patients with S-ICD implantation and explore the related factors of IAS.
详细描述
The study was a multicenter, prospective, observational study that prospectively included HCM patients assessed as meeting the ICD implantation indication at Fuwai Hospital and National Collaborative Hospitals from July 1, 2024 to June 30, 2027, for pre-operation screening of S-ICD, and follow-up of patients eventually implanted with S-ICD.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HCM patients assessed as meeting the ICD implantation indication
排除标准
- •Combined with bradycardia with pacing indications;
- •Frequent monomorphic ventricular tachycardia require ATP therapy;
- •With indications of CRT;
- •Combined with other diseases, life expectancy is less than 1 year.
结局指标
主要结局
the failure rate of S-ICD screening
时间窗: 3 months
S-ICD screening failed
The inappropriate shock event
时间窗: 3 months
The incidence of inappropriate shock event
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
S-ICD® System IDE Clinical StudyTachycardia, VentricularNCT01064076Boston Scientific Corporation330
招募中
不适用
Yield of Implantable Cardiac Monitoring Device in Patients With Acute Ischemic Stroke.Stroke, AcuteStroke, IschemicStrokeAtrial FibrillationNCT05494034National and Kapodistrian University of Athens200
Unknown
不适用
Prospective Clinical Registry of Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (S-ICD Korea Registry)Heart FailureVentricular TachycardiaSudden Cardiac DeathNCT04127643Yonsei University300
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
已完成
不适用
SCREENING FOR THE IMPLANTATION OF A SUBCUTANEOUS IMPLANTABLE AUTOMATIC DEFIBRILLATORImplantable DefibrillatorSudden Cardiac DeathNCT04101253Centre Hospitalier de PAU480