MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

Study Overview
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Brief Summary
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Clinical validation study of the MyoVista wavECG.

Detailed Description
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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.

Official Title
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MyoVista wavECG Clinical Validation Study

Conditions
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Cardiac Disease

Intervention / Treatment
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* Device: MyoVista wavECG Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| At Risk Echo Referrals<br>Study subjects will be drawn from patients who are at-risk for cardiac disease and who have been referred for 2D transthoracic echocardiogram as standard of care. All will receive a MyoVista wavECG test. | Device: MyoVista wavECG Test<br>* The MyoVista wavECG is a standard 12-Lead high-performance, multi-channel resting interpretive electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | 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. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | Sensitivity and specificity of the MyoVista for classification of Low e' versus echocardiogram where a positive includes Borderline, Positive and Highly Positive MyoVista Device outcomes. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Ventricular Diastolic Dysfunction, Electrocardiograph