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临床试验/NCT03549806
NCT03549806已完成不适用

Stanford Cardiac Invasive Electrophysiology Novel Computer Experience (SCIENCE)

Stanford University1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
11
试验地点
1
主要终点
Freedom from arrhythmia on follow-up

研究概览

简要总结

This study will test the ability of computer algorithms to predict successful ablation therapy for atrial arrhythmias.

详细描述

Patients will be recruited prospectively from among those undergoing ablation for atrial fibrillation (AF) or atrial tachycardias (AT) which may be reentrant or focal. Each patient will undergo careful data collection, including electrogram data and sites of ablation lesions. Ablation will proceed in operator-dependent fashion, and will not be modified in any way for this study. The research question is whether algorithms based on data such as electrograms and details of the ablation performed can predict which patients will have a successful case. Primary endpoints are measures of clinical success defined by (a) acute termination of atrial arrhythmia during the case; (b) long-term reduction in arrhythmia burden; (c) long-term freedom from arrhythmia. Secondary endpoints include (a) identification of sites of arrhythmia termination; (b) improved clinical status.

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

入选标准

  • Patients undergoing catheter ablation for atrial arrhythmias

排除标准

  • Inability to sign informed consent
  • Expected survival < 1 year
  • Extreme comorbidity, such as advanced NYHA Class III/IV heart failure, dialysis, series stroke.

结局指标

主要结局

Freedom from arrhythmia on follow-up

时间窗: 2 years

Absence of arrhythmia, defined by clinical thresholds.

Reduction in AF burden on follow-up

时间窗: 2 years

Reduction in amount of arrhythmia per unit time, compared to prior to the procedure.

次要结局

  • Clinical status as measured by the EQ5D(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanjiv Narayan, MD, PhD

Professor of Medicine (CV Medicine)

Stanford University

研究点 (1)

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