Status:
UNKNOWN
MyoVista wavECG Clinical Validation Study Versus Low e' on Echocardiogram
Lead Sponsor:
Heart Test Laboratories, Inc.
Conditions:
Cardiac Disease
Eligibility:
All Genders
22+ years
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-ris...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
575 Patients enrolled
Trial Details
Trial ID
NCT04804969
Start Date
May 10 2021
End Date
November 30 2023
Last Update
September 21 2023
Active Locations (5)
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1
Scripps Memorial Hospital
La Jolla, California, United States, 92037
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Montefiore Medical Center
The Bronx, New York, United States, 10467
4
Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141