NCT04559061已完成不适用
Clinical Validation of the Vektor Computational ECG Mapping System (vMap™) for Atrial and Ventricular Arrhythmias/Pacing
Vektor Medical4 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2020年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 试验地点
- 4
- 主要终点
- Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.
研究概览
简要总结
This is a retrospective, multi center clinical study collecting existing, de-identified subject data from medical records to be analyzed using an independent core laboratory to validate performance of a computational ECG mapping system (vMap™).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has one of the following clinical arrhythmia/pacing types:
- •Atrial pacing
- •Atrial fibrillation
- •Ventricular pacing
- •Premature ventricular complex
- •Ventricular tachycardia
- •Ventricular fibrillation
- •Focal atrial tachycardia
- •Premature atrial complex
- •Atrioventricular reentrant tachycardia
- •Patient has undergone 'successful' routine, standard of care diagnostic electrophysiology (EP) study using intracardiac catheters as clinically indicated, guided by fluoroscopy and routine electroanatomic mapping, intracardiac echocardiography, and/or cardiac imaging such as CT or MRI.
- •Patient has 12 lead electrogram data of clinical rhythms recorded on electrogram recording system.
- •Patient has undergone a successful ablation procedure.
- •Arrhythmia type and atrial/ventricular characteristics can be abstracted from patient medical records.
- •Patient was between 22 and 100 years of age at time of EP study and ablation procedure.
排除标准
- •Patients with unstable coronary artery disease, confirmed intracardiac thrombus, active sepsis, complex congenital heart disease, dextrocardia, severe pulmonary hypertension, decompensated heart failure, a mechanical heart valve, myocardial infarction within 1 month of ablation, inability to induce arrhythmia, unacceptable ECG data quality, and/or data included in the device training dataset.
结局指标
主要结局
Rate of accuracy/agreement of vMap™ in correctly identifying the ventricular chamber/region of the arrhythmia for PCV and VT.
时间窗: Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.
次要结局
- Rate of accuracy/agreement of vMap™ in correctly identifying the chamber/region of the arrhythmia location for all arrhythmia types.(Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.)
- Rate of accuracy/agreement of vMap™ in correctly identifying the segment of the arrhythmia treatment across all arrhythmia types.(Immediately post ablation procedure through approximately 6 months post ablation procedure, based on retrospective data collection eligibility criteria.)
研究者
研究点 (4)
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