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Clinical validation study of the MyoVista wavECG.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| At Risk Echo Referrals | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyoVista wavECG Test | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects with risk factors for cardiac disease or suspected of having cardiac disease during clinical assessment and have been referred to the site for 2D transthoracic echocardiogram.
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| Name | Affiliation | Role |
|---|---|---|
| Partho Sengupta, MD | Robert Wood Johnson University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Memorial Hospital | La Jolla | California | 92037 | United States | ||
| Beth Israel Deaconess Medical Center |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D018754 | Ventricular Dysfunction |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Einstein Medical Center | Philadelphia | Pennsylvania | 19141 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75204 | United States |