MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

Sponsor

Heart Test Laboratories, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04804969

Collaborator

(none)

575

Enrollment

Locations

13.7

Anticipated Duration (Months)

115

Patients Per Site

8.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Clinical validation study of the MyoVista wavECG.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Device: MyoVista wavECG Test

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

575 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

MyoVista wavECG Clinical Validation Study

Actual Study Start Date :

May 10, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: MyoVista 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.

Arm

Intervention/Treatment

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.

Device: MyoVista 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Scripps Memorial Hospital	La Jolla	California	United States	92037
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Montefiore Medical Center	Bronx	New York	United States	10467
4	Einstein Medical Center	Philadelphia	Pennsylvania	United States	19141
5	University of Texas Southwestern Medical Center	Dallas	Texas	United States	75204

Sponsors and Collaborators

Heart Test Laboratories, Inc.

Investigators

Principal Investigator: Partho Sengupta, MD, Robert Wood Johnson University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heart Test Laboratories, Inc.

ClinicalTrials.gov Identifier:

NCT04804969

Other Study ID Numbers:

HS-CLINVAL-001

First Posted:

Mar 18, 2021

Last Update Posted:

May 4, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Heart Test Laboratories, Inc.

Left Ventricular Diastolic Dysfunction

Electrocardiograph

Additional relevant MeSH terms:

Heart Diseases

Study Results

No Results Posted as of May 4, 2022