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 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT05864456
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥ 65 years ;
2. Patients with symptomatic severe aortic valve stenosis (evaluated by echocardiography: transaortic valve pressure gradient ≥40mmHg (1mmHg=0.133kPa), or transaortic valve blood flow rate ≥4m/s, or aortic Valve area\<1.0cm², or AVA \<0.5cm² /m²);
3. Cardiac function NYHA ≥ II;
4. Life expectancy\> 12 months;
5. Patients who are anatomically suitable for transcatheter aortic valve implantation;
6. Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
7. Patients who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Exclusion Criteria:
1. Acute myocardial infarction occurred within 1 month before this treatment;
2. Congenital unicuspid aortic valve;
3. Any therapeutic cardiac operation that is performed within 30 days of the index procedure (Previous PCI or implantation of a permanent pacemaker are not considered exclusion criteria);
4. Patients with other prosthetic heart valves, prosthetic rings already implanted in the heart, or severe mitral valve closure insufficiency (\>3+);
5. Patients with hematologic disorders or abnormalities that make surgical treatment inappropriate;
6. Untreated severe coronary artery stenosis that requires revascularization;
7. Patients with hemodynamic or respiratory instability, requiring continuous mechanical heart assistance or mechanical ventilation;
8. Patients who need emergency surgery for any reason;
9. Patients with hypertrophic cardiomyopathy with obstruction;
10. Severe left ventricular dysfunction, left ventricular ejection fraction (LVEF) \<20%;
11. Echocardiographic evidence of intracardiac mass, thrombus or vegetation;
12. Patients with left ventricular outflow tract obstruction;
13. A history of acute peptic ulcer or upper gastrointestinal bleeding within 3 months;
14. Patients who are allergy or resistance to cobalt-chromium alloy, contrast agents and related components;
15. Patients who are unable to receive anticoagulation or antiplatelet therapy;
16. Cerebrovascular accident occurred within 3 months, not including transient ischemic attack;
17. Severe aortic diseases, including abdominal aortic or thoracic aortic aneurysm, etc;
18. Active infective endocarditis or other active infections;
19. Patients who have participated in clinical trials of other drugs or medical devices before enrollment and have not yet reached the primary outcome of research;
20. The investigator judged that patient with poor compliance and could not complete the study as required.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT05864456
Study Brief:
Protocol Section:
NCT05864456