Esophageal 3D Mapping System for Cardiac Arrhythmias: Pilot Study to Establish Basis for Improved Arrhythmia Diagnostics Using the esoECG-3D Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Accuracy of focal trigger localization by esophageal mapping system
研究概览
简要总结
The aim of the study is to develop and validate a novel esophageal mapping system to improve the diagnostics of cardiac arrhythmias. Using a newly designed esophageal ECG catheter, esophageal ECGs (eECGs) will be recorded in 40 patients during an electrophysiological (EP) study and/or ablation procedure and in 12 healthy volunteers. In parallel acquired intracardiac electrograms will serve as reference for the developed mapping systems accuracy. Additionally, the esophageal mapping system will be compared to that of the standard 12-lead surface ECG in regard to its diagnostic performance.
详细描述
Background
Cardiac arrhythmias are common and may have devastating consequences for affected patients. To prevent f.e. strokes due to atrial fibrillation, heart failures as a consequence of long-standing tachyarrhythmias or death due to ventricular fibrillation, accurate and timely diagnoses are essential. The standard diagnostic tool for heart rhythm disorders in everyday clinical life is the 12-channel surface electrocardiogram (ECG). However, despite its strengths, the surface ECG suffers from several limitations. Especially on the supraventricular level, the low atrial signal amplitude renders it prone to errors and causes surface ECGs to quickly reach the limits of their diagnostic capacities.
This limitation could be overcome by recordings through the esophagus. Owing the close anatomical relationship, esophageal ECGs have an excellent atrial signal quality. To fully exploit their potential, a novel esophageal ECG catheter (esoECG catheter) with 3-dimensional electrode arrangement was developed. The aim of this study is to use the esoECG-3D catheter to develop and validate a non-invasive esophageal mapping system in order to improve the diagnostics of cardiac arrhythmias and consequently the therapy of patients suffering from these disorders.
Objectives
Primary objective (A1): Development of an esophageal non-invasive mapping system which shall be able to depict
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent as documented by signature
- •Age >18 years
- •Group 1: Patients scheduled for an elective electrophysiological study and/or ablation procedure including a transseptal passage
- •Group 2: Patients, scheduled for an elective electrophysiological study and/or ablation procedure without transseptal passage
- •Group 3: Healthy volunteers, without any known cardiac disease
排除标准
- •Contraindications to the class of devices under study, e.g. known hypersensitivity or allergy to class of devices or the investigational device
- •Status post atrial fibrillation ablation within the last 4 weeks
- •Unstable angina pectoris or acute coronary syndrome
- •Hemodynamic instability
- •Respiratory instability
- •Disease or malformation of the upper airways or esophagus, making naso-esophageal catheter insertion impossible
- •Hereditary severe bleeding diathesis
- •Status post surgical intervention of the esophagus or stomach within the last 4 weeks
- •Known cancer of the esophagus or stomach
- •Pregnancy
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
结局指标
主要结局
Accuracy of focal trigger localization by esophageal mapping system
时间窗: within 1 year after study completion
Reference: intracardiac recordings
Accuracy of cardiac activation sequence estimation by esophageal mapping system
时间窗: within 1 year after study completion
Reference: intracardiac recordings
次要结局
- Diagnostic performance of esophageal mapping system compared to standard 12-channel ECG(within 1 year after study completion)
- Accuracy of depolarization propagation speed estimation from eECGs (acquired with IMD)(within 1 year after study completion)
- Incidence of Adverse Events [Safety and Tolerability](up to 12 hours after study completion)
- Accuracy of respiration estimation from eECGs (acquired with IMD)(within 1 year after study completion)