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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT04678934
Eligibility Criteria:
Inclusion Criteria:
* Patients voluntarily participated and signed informed consent;
* Patients with severe aortic stenosis undergo TAVR after assessment by the Heart Team; \[Definition of severe aortic stenosis: mean aortic pressure gradient (MPG) ≥ 40 mmHg, aortic valve area (AVA) ≤ 1.0 cm2 and maximal aortic velocity (Vmax) ≥ 4 m / s.\] ③ Age ≥ 65 years old.
Exclusion Criteria:
* Emergency procedure;
* Severe cognitive impairment (MMSE \< 15), or years of education \< 6 years;
* Unstable condition (intractable angina pectoris, acute heart failure) or patients can not complete MRI examination or cognitive assessment;
* TAVR operation failed or transferred to surgery for SAVR due to serious complications; ⑤ Speech disorders, or mental disorders, or severe physical disorders (MRS ≥ 3); ⑥ Patients with complicated congenital heart disease, HCM, surgery valve replacement or combined valvular disease; ⑦ Patients with life expectancy less than 12 months.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT04678934
Study Brief:
Protocol Section:
NCT04678934