Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-24 @ 11:13 PM
NCT ID:
NCT04804969
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Study:
NCT04804969
Study Brief:
Protocol Section:
NCT04804969