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 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT06277960
Eligibility Criteria:
Inclusion Criteria:
1. 18 years old ≤ age ≤ 75 years old, no gender limit.
2. Subject has pressure gradient of left ventricular outflow tract (LVOT) ≥50 mmHg（with Systolic Anterior Motion）in the resting-state or after exercise stress test.
3. Subject with New York Heart Association (NYHA) cardiac function ≥ II grade.
4. Subject with adequate drug treatment is not effective or cannot tolerate side effects of the drug.
5. Subject was informed of the nature of the clinical study and agreed to participate in all the requirements of the clinical study, signed an ethics committee-approved informed consent form before conducting any special examinations and/or treatments related to the clinical study.
Exclusion Criteria:
1. Subject is pregnant, lactating, or planned to conceive during a clinical study.
2. Subject with interventricular septal thickness ≥ 30mm.
3. Subject has undergone other ventricular septal volume reduction surgeries.
4. Subject with complete right bundle branch block on electrocardiogram.
5. Subject with Sudden Cardiac Death Index ≥ 10%.
6. Subject combined with other heart diseases requires surgical treatment.
7. Subject with heart failure(Defined as resting heart failure after intensive anti-heart failure therapy, left ventricular fraction of ejecting\< 40%).
8. Subject is mentally incapacitated or unable to understand the study requirements.
9. Subject has participated in other clinical trials within 3 months.
10. The investigator determines that there is any situation that affects the safety of the subjects or interferes with the evaluation of test results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06277960
Study Brief:
Protocol Section:
NCT06277960