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临床试验/NCT02541175
NCT02541175已完成不适用

Paroxysmal Atrial Fibrillation Detection and Heart Beat Classification in Multi-Channel Esophageal Long-Term ECG

Insel Gruppe AG, University Hospital Bern1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Number of correct classified A/V beats in automated eECG analysis compared to manually analyzed surface ECG

研究概览

简要总结

This study is designed to prove new methods to enable the automated analysis of esophageal electrocardiography (eECG) signals in long-term measurements as well as the detection of atrial fibrillation. The investigators hypothesis is that eECG signals allow the reliable atrial and ventricular ECG signal distinction and the detection of atrial fibrillation. Therefore 14 patients with arrhythmias and 6 cardiac healthy subjects are asked to take part in this study. On each subject an esophageal ECG and a simultaneous standard surface ECG will be taken for about half an hour. Patient undergoing a cardiac catheter ablation during their current hospitalization will be further asked to allow access to the invasively obtained measurements (i.e. atrial potential map) to further improve the understanding of the eECG signals.

详细描述

Background

The fast and correct diagnosis of heart rhythm disorders is very important to reduce morbidity and mortality in cardiovascular patients. Atrial fibrillation is of special interest, because it is an important cause of devastating brain strokes. A significant number of strokes have a cardioembolic genesis due to paroxysmal atrial fibrillation which was not diagnosed early enough. Therefore, it is very important to detect atrial fibrillation as soon as possible. With oral anticoagulation an effective therapeutic option in available to prevent cardioembolisms.

In the clinical routine, mostly 24-hour or 7-day ECGs are made to look for cardiac arrhythmias. The use of such devices is well established. Nevertheless, they have some side effects/limitations. Skin electrodes used for derivation of the ECG often cause skin irritation, sometimes leading to premature termination of the recording. Because of dryout of the contact gel (causes artifacts), small p-waves and especially also motion artifacts, triggered recording or semi-automatic analysis of the recording is problematic, but for longer recording times such a semi-automatic analysis would be helpful. As an alternative esophageal electrocardiography can be performed. Signal quality of the ECG recording (especially of the left atrium) is better than in the standard surface ECG because of the vicinity of the esophagus and the left atrium. The esophagus tolerates well foreign bodies as the investigators know from long-term nasogastric intubation. Therefore use of the esophageal technique for long-term rhythm monitoring is an interesting and promising alternative to conventional surface Holter ECGs.

Earlier studies have already shown the improved p-wave in eECG signals, but the automatic or semi-automatic wave analysis algorithms were not satisfactory. By increasing the number of measuring channels on the esophageal catheter, new classes of algorithm can be applied in order to increase the detection reliability. Using multiple channels to increase the quality of the result is an intuitive and widely used method e.g. in 12 lead ECG or EECG, etc.

Objective

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

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

入选标准

  • Age >/= 18 years
  • Written informed consent
  • ambulatory/hospitalized due to peripheral percutaneous intervention
  • ambulatory/hospitalized due to shunt stenosis or occlusion
  • ambulatory/hospitalized due to electrophysiological intervention
  • ambulatory/hospitalized due to pacemaker implantation
  • ambulatory/hospitalized due to decompensated heart failure
  • ambulatory/hospitalized due to planed cardioangiography
  • ambulatory/hospitalized due to performed cardioangiography after Non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI)
  • cardiac healthy adults
  • Exclusion Criteria
  • History of ablation of atrial fibrillation
  • History of heart transplantation
  • Instable angina pectoris/acute myocardial infarction before revascularisation
  • Cardiorespiratory unstable patients
  • History of valve replacement operation less than 4 weeks ago
  • Obstructive cardiomyopathy with severe dynamic Left Ventricular Outflow Tract (LVOT) obstruction
  • Known severe bleeding diathesis
  • Known malformations or disease in the upper airways, conflicting with the catheter insertion
  • Known malformations or disease in the esophagus, conflicting with the catheter insertion
  • Uncontrolled arterial hypertonia (syst. blood pressure > 200mmHg)
  • Pregnancy

排除标准

  • 未提供

结局指标

主要结局

Number of correct classified A/V beats in automated eECG analysis compared to manually analyzed surface ECG

时间窗: during analysis of ECG (approx. 30 minutes records)

次要结局

  • Number of correctly detected atrial fibrillation sequences in automated eECG analysis compared to manually analyzed surface ECG(during analysis of ECG (approx. 30 minutes records))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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