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 @ 2:02 PM
Ignite Modification Date:
2025-12-24 @ 2:02 PM
NCT ID:
NCT06211595
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 18 years
2. Obstructive hypertrophic cardiomyopathy, peak LVOT pressure difference ≥50mmHg at rest or after excitation;
3. Obvious clinical symptoms, fatigue, shortness of breath, fatigue angina pectoris, syncope, etc., seriously affect the quality of life, and adequate drug treatment is not effective or can not tolerate drug side effects, after evaluation, transaortic interventional surgery can be performed;
Exclusion Criteria:
1. Women who are pregnant, breastfeeding, or planning to become pregnant;
2. interventricular septum thickness ≥30mm;
3. non-hypertrophic obstructive cardiomyopathy;
4. Presence of cardiac neoplasms;
5. A history of interventricular septal resection or alcohol ablation, or Liwen surgery;
6. Combined with other heart diseases requiring surgical treatment;
7. Heart failure (after intensive anti-heart failure treatment, there are still symptoms of resting heart failure, such as left ventricular ejection fraction \< 50%, N-terminal -B type natriuretic peptide precursor, NT-pro BNP≥5000pg/ml, pulmonary edema, pleura or pericardial effusion, etc.);
8. Significant coronary lesions, or borderline lesions, requiring coronary revascularization due to mismatch between coronary perfusion and demand (QFR or FFR \< 0.8), or coronary ischemic events within 30 days;
9. Bleeding diseases or clotting disorders; Or there is a contraindication of antithrombotic drug therapy;
10. estimated Glomerular Filtration Rate (eGFR) \< 35ml/min;
11. Life expectancy was less than 12 months, and the investigator judged that the patient had poor compliance and could not complete the study as required; Or other circumstances in which the investigator considers the subject unsuitable for the study;
12. Subject is currently participating in an investigational drug or device study that has not completed its primary endpoint or that would clinically interfere with the endpoint of this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06211595
Study Brief:
Protocol Section:
NCT06211595