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:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT07155434
Eligibility Criteria:
Inclusion Criteria:
1. Male and female subjects aged 18 years or over at the time of screening.
2. Willing and able to give written informed consent.
3. New York Heart Association (NYHA) Class I to III
4. Eligible to receive or currently receiving CamzyosTM per product labelling.
Exclusion Criteria:
1. Emergency (non-elective) admission within 24 hours prior to participating in the study.
2. Unable to lie down as required in all the classic positions for standard TTE exam: supine on back/left decubitus.
3. Subjects who had technically difficult exam in the past, due to body habitus, upon investigator's discretion.
4. Subjects with body mass index (BMI) above 40 kg/m2.
5. Subjects experiencing a known or suspected acute cardiac event.
6. Subjects with severe chest wall deformities as per previous medical records and physical examination.
7. Subjects who have undergone pneumonectomy.
8. 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.).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07155434
Study Brief:
Protocol Section:
NCT07155434