NCT03893331终止不适用
AcQMap® Global Registry of Procedural and Long-term Clinical Outcomes (AcQMap Registry)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 479
- 试验地点
- 12
- 主要终点
- Procedural Ablation Outcomes
研究概览
简要总结
AcQMap Registry is an observational study
详细描述
AcQMap Registry is an observational, prospective, multi-center, multi-national, 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 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
研究点 (12)
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