Clinical trial NCT04804969: MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Official title: MyoVista wavECG Clinical Validation Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cardiac Disease
Keywords: Left Ventricular Diastolic Dysfunction
Electrocardiograph
Lead sponsor: Heart Test Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 575
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and Specificity
timeFrame: Baseline
Secondary outcomes:
measure: Sensitivity and Specificity
timeFrame: Baseline
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Robert Wood Johnson University Hospital
name: Partho Sengupta, MD
role: PRINCIPAL_INVESTIGATOR
References: