跳至主要内容
临床试验/NCT03331029
NCT03331029Unknown不适用

Assessment of Left Atrial Mechanical Function With a True 3D Ultrasound Array and Comparison With the Transthoracic and Transesophageal Echocardiography: A Single Center Interventional Study in Patients Scheduled for Ablation Procedure

Klinik Hirslanden, Zurich1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
changes in left atrial appendage flow

研究概览

简要总结

Chronic atrial fibrillation is a challenging arrhythmia requiring additional radiofrequency ablation besides pulmonary vein isolation. Atrial contractility in these patients is often impaired. Until now mapping catheters were used on virtual geometry maps of left atrium. However, changes in atrial volume cannot be assessed with these systems Assessments of atrial volumes with echocardiography relies on 2D and 3D measurements and modeling. The AcQMapTM 3D High Resolution Imaging and Mapping System (AcQMap) has a unique 3D array of ultrasound crystals, which can measure true 3D dimensions of the heart chamber. For the first time, true atrial volumes can be measured. Changing from atrial fibrillation to sinus rhythm causes changes in atrial volume and might be associated with quantitative systolic and diastolic function of the left ventricle measured with the Transesophageal Echocardiography.

详细描述

Comparison of true 3D atrial volume changes to TEE and TTE findings as well as atrial pressure curves during left heart catheterization. Changing from atrial fibrillation to sinus rhythm causes changes in atrial volume and might be associated with quantitative systolic and diastolic function of the left ventricle measured with the Transesophageal Echocardiography

Measurement of true left atrial ejection fraction and comparison to 2D echocardiographic parameters such as transesophageal measured flow velocity of the mitral inflow tract, pulmonary vein flow, the left atrial appendage flow

Inclusion:

Patients undergoing electrophysiological study with the AcQmap System Age ≥18 years and signed informed consent German speaking

Exclusion:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • •Patients undergoing electrophysiological study with the AcQmap System
  • •Age ≥18 years and signed informed consent
  • •German speaking

排除标准

  • •Mechanical mitral valve
  • •Contraindication for left atrial ablation procedure such as: Intra-cardiac clot,
  • •Pregnancy

研究组 & 干预措施

transesophageal echocardiography

Other

Comparison of 3D Ultrasound with transesophageal echokardiography

干预措施: transesophageal investigation (Device)

结局指标

主要结局

changes in left atrial appendage flow

时间窗: 1 hour

Changes in Mitral flow velocity

时间窗: 1 hour

changes in pulmonary vein flow

时间窗: 1 hour

次要结局

未报告次要终点

研究者

发起方
Klinik Hirslanden, Zurich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Werner Baulig

PD Dr. med. Werner Baulig, Senior consultant

Klinik Hirslanden, Zurich

研究点 (1)

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