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 @ 7:24 PM
Ignite Modification Date:
2025-12-24 @ 7:24 PM
NCT ID:
NCT05067803
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 and older
2. Subjects willing and able to give written informed consent.
Exclusion Criteria:
1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (WOCBP\* will perform a urine pregnancy test)
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus.
4. Subjects who currently participate a clinical trial, involving interventional cardiac devices
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report
6. Subjects with BMI above 40
7. Subjects experiencing a known or suspected acute cardiac event
8. Subjects with severe chest wall deformity as per previous medical records and physical examination
9. Subjects who have undergone pneumonectomy
10. Subjects whose anatomy does not lend itself to yield diagnosable echocardiography clips (i.e. situs inversus with dextrocardia, single ventricle anatomy due to congenital heart defect, etc.)
* A woman is of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Müllerian agenesis.)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05067803
Study Brief:
Protocol Section:
NCT05067803