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NCT04678934: CLEVER-TAVR

Cerebral Lesion and Neurocognitive Status Changes After TAVR

Status unknown Last updated 24 December 2020
What this trial tests

trial testing TAVR in Aortic Stenosis in 200 participants. Status unknown.

Timeline
1 January 2021
Primary endpoint
31 December 2021
31 December 2022

Quick facts

Lead sponsorSecond Xiangya Hospital of Central South University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment200
Start date1 January 2021
Primary completion31 December 2021
Estimated completion31 December 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Second Xiangya Hospital of Central South University

Who can join

65 and older, any sex, with Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of TAVR

Trials testing the same drug.

Other recruiting trials for Aortic Stenosis

Currently open trials in the same condition.

Other Second Xiangya Hospital of Central South University trials

Trials by the same sponsor.

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Data sources for this page

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