NL-OMON54422招募中不适用
Safety and Performance of Invicta ventricular DF4 leads with active fixation. - APOLLO
Microport CRM B.V.0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Indication for an ICD or CRT-D implant, according to ESC guidelines.
- •2. Scheduled for a de novo implant of an ICD (VR, DR) or CRT-D, manufactured by
- •Microport CRM, equipped with a DF4-connector.
- •3. Dated and signed Informed Consent.
排除标准
- •1. Tricuspid valvular disease, or tricuspid valve replacement of any kind.
- •2. Transient tachy-arhythmias due to reversible causes.
- •3. Contra-indication to a maximum single dose of 330 ug dexamethasone sodium
- •phosphate (DSP).
- •4. Active myocarditis.
- •5.Previous implant of a pacemaker, ICD or CRT-D device and leads.
- •6. Enrolled in another study that may confound the results of the Apollo study.
- •7. Inability to understand the purpose of the study.
- •8. Under the age of 18.
- •9. Pre-menopausal women.
- •10. Drug addiction or drug abuse.
- •11. Life expectancy less than 1 year.
研究者
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Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)Ventricular ArrythmiaLeadICDHeart FailureNCT04590144MicroPort CRM446
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