Non-invasive Tool to Assess Electrophysiological Mechanisms in Cardiac Arrhythmias (SAVE-COR)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 362
- 试验地点
- 3
- 主要终点
- Accuracy of ECGI for detecting cardiac region of interest
研究概览
简要总结
Noninvasive evaluation of the electrical status of the heart is based on the standard ECG but remains suboptimal due to difficulties with arrhythmia characterization and location. Electrocardiographic Imaging (ECGI) provides maps of cardiac electrical excitation in relation to the anatomy of the heart using an extensive number of electrodes from the body surface. The applicant will develop a systematic evaluation of the ECGI as a tool to detect cardiac regions of interest in cardiac arrhythmias.
详细描述
The specific aim of this multicenter observational study is to evaluate the precision of non-invasive cardiac mapping system ECGI using multipolar intracardiac recordings as the gold standard. We will develop a non-invasive ECGi and intracardiac recordings in patients undergoing electrophysiology studies and/or intracardiac devices implantation to correlate the position of the regions of interest at predefined anatomy sites in patients with different organized arrhythmias. The long-term outcome of the electrophysiological characterization using ECGI will be also evaluated. Finally, the cost-efficiency of ECGI system as a support tool in cardiac arrhythmias diagnosis will be assessed.
Objectives: to perform a systematic evaluation of the ECGI with recordings using multipolar intracardiac recordings as the gold standard. Secondly, the study will also validate the ability of the ECGI recordings to increase the precision of the standard ECG interpretation by an expert.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •Indication for an invasive electroanatomic study and/or intracardiac device implantation.
- •Having obtained and signed the informed consent for study participation.
- •Ability to stand, to be able to obtain the 3D torso reconstruction necessary for the ECGI system.
排除标准
- •<18 years old
- •Inability to perform an endocardial catheterization and/or device implantation.
- •Physical or mental disability to understand and accept the informed consent.
- •Inability to stand to obtain the 3D torso reconstruction.
- •active coronary ischemia or decompensated heart failure
- •Intracardiac clot on trans-esophageal echocardiography
- •Pregnancy.
- •Disorganized arrhythmias (i.e. atrial fibrillation, polymorphic ventricular tachycardia).
研究组 & 干预措施
Groups/Cohorts
Patients undergoing intervention for arrhythmia (electrophysiologic study and/or intracardiac device implantation) with clinical indication
干预措施: ACORYS MAPPING SYSTEM (Device)
结局指标
主要结局
Accuracy of ECGI for detecting cardiac region of interest
时间窗: 1 year
Accuracy of the ECGI non-invasive cardiac mapping system for detecting cardiac regions of interest in cardiac arrhythmias through direct confrontation with invasive endocardial contact measures.
次要结局
- ECGI's ability to accurately predict the success of ablation procedures and recurrence(1 year)
- Correlation of ECGI with an expert's interpretation of the standard ECG(1 year)
- Cost-effectiveness rate of the ECGI(1 year)