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 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT02888132
Eligibility Criteria:
Inclusion Criteria:
* Subject who cannot tolerate ventricular septum resection or transcatheter ethanol ablation and volunteer for the operation
* Subject meets HOCM diagnosis standards verified by the echocardiogram; the obstruction is located in the basal part of ventricular septum
* Subject has significant clinical symptoms, including progressively increasing fatigue, angina, exertional dyspnea, and syncope; subject receives poor effect after drug therapy or cannot tolerate side effects of medication
* 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
* Subject over 18 years old
Exclusion Criteria:
* Subject has non-obstructive hypertrophic cardiomyopathy
* Subject has combined cerebral vascular diseases
* Subject has diseases that must receive surgeries, including severe mitral valve lesions and coronary heart disease which requires coronary artery bypass grafting.
* Subject has end-stage heart failure
* Subject has intraventricular septal thickness (IVST) ≥ 30mm
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02888132
Study Brief:
Protocol Section:
NCT02888132