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临床试验/jRCT2032250125
jRCT2032250125尚未招募不适用

Aveir LP Post Marketing Surveillance

Abbott Medical Japan LLC0 个研究点目标入组 304 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
304
主要终点
3-year Aveir DR LP system complication-free rate
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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
No limit 至 No limit（—）
性别
All

入选标准

  • •Target patients should be selected in accordance with the device IFU, JCS/JHRS pacing guidelines and the JHRS Statement. All patients with an attempted dual-chamber Aveir DR or single-chamber atrial Aveir AR implant are expected to be approached regarding the PMS(Post Marketing Surveillance). The following patients who agree to participate in the surveillance upon signing an Informed Consent form, are indicated for dual-chamber or single-chamber atrial LPs, and have tried therapy with the Aveir LP will be registered:
  • •Patients indicated for de novo dual-chamber LP's
  • •Patients indicated for a de novo atrial LP
  • •Upgrade Patients
  • •Rollover patients from the Aveir DR i2i IDE study will participate in the surveillance upon their consent

排除标准

  • 未提供

结局指标

主要结局

3-year Aveir DR LP system complication-free rate

时间窗: 3-year

The primary endpoint evaluates the complication-free rate of the Aveir DR LP system in de novo Aveir DR patients over a 3-year period.

次要结局

未报告次要终点

研究者

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Aveir LP Post Marketing Surveillance | 临床试验