NCT04804969进行中（未招募）不适用
MyoVista wavECG Clinical Validation Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 575
- 试验地点
- 5
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
Clinical validation study of the MyoVista wavECG.
详细描述
This is a multi-center, non-interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram.
The study will be conducted at a minimum of three investigational sites within the United States.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment.
- •The subject provides written informed consent using an Informed Consent Form that is reviewed and approved by the site's Institutional Review Board (IRB).
- •Conventional ECG results show a sinus rhythm and no other contraindicated rhythm abnormalities (see exclusions below).
- •Subject is >/= 22 years of age
排除标准
- •The subject has current acute coronary syndrome, decompensated heart failure or stroke
- •The subject has received any prior cardiac interventions or surgical therapeutic procedures relating to cardiac abnormalities: valve replacement, pacemaker implantation, coronary artery bypass grafting (CABG), heart transplant, ablation, coronary stent placement, etc.
- •Conventional ECG results indicating a lack of sinus rhythm and/or any other contraindicated rhythm abnormalities, including: active atrial fibrillation or atrial flutter, left anterior fascicular block, left and/or right bundle branch block
- •The subject is pregnant at the time of the study testing
- •The subject has chest deformities that interfere with accurate measurement of ECG (either conventional or wavECG)
- •Subjects with central nervous system or musculoskeletal abnormalities that may interfere with accurate acquisition of ECG and/or echocardiogram measurements.
- •The subject is enrolled in another clinical study that may interfere with MyoVista or echocardiogram measurements. Exceptions to this may be approved by HeartSciences.
结局指标
主要结局
Sensitivity and Specificity
时间窗: Baseline
Sensitivity and specificity of the MyoVista for the classification of Low e' from echocardiogram where a "positive" includes Positive and Highly Positive MyoVista Device outcomes.
次要结局
- Sensitivity and Specificity(Baseline)
研究者
研究点 (5)
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