MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

MyoVista wavECG Clinical Validation Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04804969

Enrollment

575

Registered

2021-03-18

Start date

2021-05-10

Completion date

2023-11-30

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Disease

Keywords

Left Ventricular Diastolic Dysfunction, Electrocardiograph

Brief summary

Clinical validation study of the MyoVista wavECG.

Detailed description

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.

Interventions

DEVICEMyoVista wavECG Test

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and Specificity	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.

Secondary

Measure	Time frame	Description
Sensitivity and Specificity	Baseline	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026