Markers of Paroxysmal Atrial Fibrillation in Esophageal Holter Electrocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number atrial premature beats not conducted to the ventricles
研究概览
简要总结
With the use of esophageal Holter electrocardiography (eECG), the investigators will look for surrogate markers of paroxysmal atrial fibrillation. To do so, the investigators will record eECGs in patients with known paroxysmal atrial fibrillation but at the time of eECG-recording in sinus rhythm. To identify markers, the eECGs of those patients will be compared to a group of controls in sinus rhythm without atrial fibrillation. The investigators hypothesis is that it is possible to identify surrogate markers in patients with paroxysmal atrial fibrillation.
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 has 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 uf 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 we 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.
The diagnosis of paroxysmal atrial fibrillation (pAF) can only be made if an episode of atrial fibrillation occurs during the long-term ECG recording. Surrogate markers of pAF could identify a "population at risk" in which pAF has to be suspected although they show sinus rhythm during the time of recording. In surface ECG such markers have been suspected. The use of esophageal long-term electrocardiography with its better signal properties is a promising alternative to find such surrogate markers for risk stratification.
Objective
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Age >/= 18 years
- •Written informed consent
- •Hospitalized patient on the cardiology ward or referred to the cardiological ambulatory
- •Paroxysmal atrial fibrillation but in sinus rhythm at the time of inclusion (cases)
- •Sinus rhythm without known heart rhythm disorders (controls)
- •Exclusion Criteria
- •Persistent atrial fibrillation
- •Pacemaker/ICD with atrial electrode
- •History of ablation of atrial fibrillation
- •Instable angina pectoris/acute myocardial infarction before revascularisation
- •Cardiorespiratory unstable patients
- •History of heart transplantation
- •Known severe bleeding diathesis
- •Carcinoma of the esophagus or nasopharynx
- •Pregnancy
- •History of valve replacement operation less than 4 weeks ago
- •Obstructive cardiomyopathy with severe dynamic LVOT-obstruction
排除标准
- 未提供
结局指标
主要结局
Number atrial premature beats not conducted to the ventricles
时间窗: during analysis of the ECG
次要结局
- mean number of p-eso-wave-peaks(during analysis of the esophageal ECG)
- Mean duration of the left atrial wavefront(during analysis of the esophageal ECG)
- p-eso-wave-duration-dispersion(during analysis of the esophageal ECG)
- root mean square voltages of the last 20 ms of the p-eso-wave in the esophageal ECG(during analysis of the esophageal ECG)
- Mean duration of the p-eso-wave(during analysis of the esophageal ECG)