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.
Study Type
OBSERVATIONAL
Enrollment
575
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.
Scripps Memorial Hospital
La Jolla, California, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Montefiore Medical Center
The Bronx, New York, United States
Einstein Medical Center
Philadelphia, Pennsylvania, United States
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.
Time frame: Baseline
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.
Time frame: Baseline
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University of Texas Southwestern Medical Center
Dallas, Texas, United States