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Cerebral Lesion and Neurocognitive Status Changes After TAVR

NCT04678934 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2020-12-24

No results posted yet for this study

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 consecutive patients ≥65 years of age before TAVR and enroll those that complete the procedure successfully. The investigators will assess the neurocognitive function using multiple tests with Reliable Change Index before TAVR and 7, 30, 90, 180 and 360 days after TAVR. The primary endpoint will be major adverse cardiovascular and cerebral events(MACCE, defined according to the Valve Academic Research Consortium-2 data dictionary) at 1 year.

Conditions

  • Aortic Stenosis

Interventions

PROCEDURE

TAVR

Transcatheter aortic valve replacement

Sponsors & Collaborators

  • Xiangya Hospital of Central South University

    collaborator OTHER

  • The Third Xiangya Hospital of Central South University

    collaborator OTHER

  • Xiangtan Central Hospital

    collaborator OTHER

  • ZhuZhou Central Hospital

    collaborator OTHER

  • The First People's Hospital of Changde City

    collaborator OTHER

  • Xiangya Changde Hospital

    collaborator UNKNOWN

  • West China Hospital

    collaborator OTHER

  • Second Xiangya Hospital of Central South University

    lead OTHER

Principal Investigators

  • Shenghua Zhou · Second xiangya Hospital

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04678934 on ClinicalTrials.gov