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临床试验/NCT02997254
NCT02997254招募中不适用

COMparison of Physiological Algorithms for Real-time Evaluation of Atrial Fibrillation

Stanford University1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
1
主要终点
Diagnostic Accuracy

研究概览

简要总结

This is a cohort study to evaluate algorithms for mapping atrial fibrillation by mapping atrial structure and mapping electrical activity to detect physiologically important areas.

A key innovation of the observation study is to assess tracking of physiological activity in AF, in relation to tissue activity (MAP recordings), and in relation to AF waves of activity.

This observational work extends prior studies that focused on focal and rotational activity, dispersion of electrical activity, low voltage activity and others.

详细描述

In this study, the investigators will compare mapping approaches for atrial fibrillation ablation.

First, investigators will compare approaches to map atrial structure from collected computed tomography (CT) scans or magnetic resonance imaging (MRI) scans acquired routinely in patients undergoing ablation for atrial fibrillation. Imaging will be acquired from a variety of clinically approved

Second, investigators will compare approaches to analyze electrograms collected routinely at clinical electrophysiology study (EPS) in patients undergoing ablation for atrial fibrillation. Electrograms will be recorded from a variety of clinically approved catheters under standard of care conditions, and will be analyzed to better understand the mechanisms for atrial fibrillation and its relationship to outcomes. Electrograms include unipolar recordings, bipolar recordings and, monophasic action potential recordings using FDA-cleared catheters.

The investigators anticipate analyzing data from 1000 patients from inception of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 21-80 yrs who underwent electrophysiology study for ablation of Atrial Fibrillation

排除标准

  • Poor data quality of recordings of AF

结局指标

主要结局

Diagnostic Accuracy

时间窗: At time of procedure.

Comparing algorithms to segment atrial structures from computed tomography or Magnetic resonance images.

次要结局

  • Analysis Time(At time of procedure.)

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, Principal Investigator

Stanford University

研究点 (1)

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