Status:
UNKNOWN
MyoVista wavECG Clinical Evaluation: >=60 y/o Enrichment Population
Lead Sponsor:
Heart Test Laboratories, Inc.
Conditions:
Health Screening
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This is a single-center, interventional, single arm clinical study of the MyoVista wavECG for the detection of LV relaxation abnormalities. The study will be conducted at a single investigational site...
Detailed Description
The study has a planned enrollment of at least 50 subjects to obtain approximately 40 subjects with a "normal" septal and lateral e' value on echocardiogram. The criteria defined as septal e'\< 7 cm/s...
Eligibility Criteria
Inclusion
- Subject is \>=60 years of age
- Subjects will predominately be recruited among those who are already enrolled in existing registry studies within the institution.
- 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).
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 :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05364541
Start Date
June 1 2022
End Date
November 30 2023
Last Update
September 21 2023
Active Locations (1)
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1
University of Texas Medical Center
Dallas, Texas, United States, 75390