MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

MyoVista wavECG Clinical Validation Study

Clinical validation study of the MyoVista wavECG.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 575

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Memorial Hospital
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19141
      • Einstein Medical Center
  • Texas
    • Dallas, Texas, United States, 75204
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Heart Test Laboratories, Inc.
• Investigators: Principal Investigator: Partho Sengupta, MD, Robert Wood Johnson University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): November 30, 2023

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Left Ventricular Diastolic Dysfunction; Electrocardiograph
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: HS-CLINVAL-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No