跳至主要内容
临床试验/NCT04431544
NCT04431544终止不适用

AcQMap® US Registry of Procedural and Long-term Clinical Outcomes (Discover-US)

Acutus Medical25 个研究点 分布在 1 个国家目标入组 513 人开始时间: 2020年9月29日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
513
试验地点
25
主要终点
Procedural Ablation Outcomes

研究概览

简要总结

AcQMap Registry is an observation study

详细描述

AcQMap Registry is an observational, prospective, multi-center, open-label registry designed to provide clinical data regarding the commercial, real-life experience with the diagnostic AcQMap System.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female 18 years of age or older. Currently scheduled for an ablation of an arrhythmia utilizing the diagnostic AcQMap System.
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
  • Willing and able to give written informed consent.

排除标准

  • In the opinion of the Investigator, any known contraindications to an ablation procedure.
  • Current enrollment in any study protocol sponsored by Acutus Medical. Any other condition that, in the judgment of the investigator, makes the participant a poor candidate for this procedure, the study, or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, etc.).

结局指标

主要结局

Procedural Ablation Outcomes

时间窗: 12 hours

Number of participants who had termination of ablated arrhythmia's to Sinus Rhythm or another arrhythmia within 12 hours post ablation procedure with or without electrical or pharmacological cardioversion

次要结局

  • Long-term Outcome(3 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (25)

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