Brief Summary
Clinical validation study of the MyoVista wavECG.
Brief Title
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
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.
The study will be conducted at a minimum of three investigational sites within the United States.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Cardiac Disease
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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Left Ventricular Diastolic Dysfunction
Electrocardiograph
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
22 Years
NCT Id
NCT04804969
Org Class
Industry
Org Full Name
Heart Test Laboratories, Inc.
Org Study Id
HS-CLINVAL-001
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
MyoVista wavECG Clinical Validation Study
Primary Outcomes
Outcome Description
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.
Outcome Measure
Sensitivity and Specificity
Outcome Time Frame
Baseline
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Baseline
Outcome Measure
Sensitivity and Specificity
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
22
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- HEART DISEASES
Heart/Cardiovascular --- HEART DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
HEART DISEASES
VENTRICULAR DYSFUNCTION, LEFT
CARDIOVASCULAR DISEASES
VENTRICULAR DYSFUNCTION