Status:
UNKNOWN
Cerebral Lesion and Neurocognitive Status Changes After TAVR
Lead Sponsor:
Second Xiangya Hospital of Central South University
Collaborating Sponsors:
Xiangya Hospital of Central South University
The Third Xiangya Hospital of Central South University
Conditions:
Aortic Stenosis
Eligibility:
All Genders
65+ years
Brief Summary
The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter observational cohort study. The investigators will screen conse...
Detailed Description
Study Design The CLEVER-TAVR cohort (Cerebral Lesion and Neurocognitive Status Changes after Transcatheter Aortic Valve Replacement) is a multicenter prospective observational study. Patients with aor...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04678934
Start Date
January 1 2021
End Date
December 31 2022
Last Update
December 24 2020
Active Locations (1)
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1
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011