MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

Cardiac Disease Clinical Trial

Official title:

MyoVista wavECG Clinical Validation Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04804969
• Other study ID #: HS-CLINVAL-001
• Status: Active, not recruiting
• Start date: May 10, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2023
• Source: Heart Test Laboratories, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Clinical validation study of the MyoVista wavECG.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 575
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Scripps Memorial Hospital	La Jolla	California
United States	Einstein Medical Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Heart Test Laboratories, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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