MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

Active, not recruiting

• Conditions: Cardiac Disease

• Registration Number: NCT04804969
• Lead Sponsor: Heart Test Laboratories, Inc.

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.

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-05-10
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-20
• Last Update Posted: 2023-09-21
• Primary Completion: 2023-11-30
• Study Completion: 2023-11-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 575

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (5)

Scripps Memorial Hospital; 🇺🇸 La Jolla, California, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States

Einstein Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States