MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram

Status unconfirmed

Conditions studied: Cardiac Disease

In brief

Clinical validation study of the MyoVista wavECG.

Key facts

Study ID

NCT04804969

Run by

Heart Test Laboratories, Inc.

People needed

575

Starts

2021-05-10

Expected to finish

2023-11-30

Last updated by the study team

2023-09-21

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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