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Cerebral Lesion and Neurocognitive Status Changes After TAVR — CLEVER-TAVR  

Aortic Stenosis Clinical Trial

Official title:
Cerebral Lesion and Neurocognitive Status Changes After Transcatheter Aortic Valve Replacement：A Prospective Multicenter Observational Cohort Study.

Clinical Trial 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.

Clinical Trial 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 aortic stenosis who successfully undergo TAVR procedure from January 2021 to December 2021 will be enrolled in this study according to the inclusion criteria. Preoperative cognitive function, DW-MRI evaluation and baseline data will be recorded. All patients should be followed up for 1 year, including telephone follow-up once a month to record the main end-point events, and clinic follow-up at 30, 90, 180, 360 days after TAVR. Laboratory examination, electrocardiogram, color Doppler ultrasound and other examinations will be collected and recorded. The changes of cognitive function and brain imaging (DW-MRI) will be evaluated before discharge(7 days), 30, 90, 180, 360 days after procedure. The primary endpoint will be major adverse cardiovascular and cerebral events(MACCE), including all-cause death, stroke, acute kidney injury, myocardial infarction, bleeding complications, vascular complications, permanent pacemaker implantation, conduction block and arrhythmia, valve related complications. The postoperative valve function, life quality and other complications related to TAVR will also be recorded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04678934
Study type Observational [Patient Registry]
Source Second Xiangya Hospital of Central South University
Contact Shenghua Zhou
Phone +8673185292012
Email zhoushenghua@csu.edu.cn
Status Not yet recruiting
Phase
Start date January 1, 2021
Completion date December 31, 2022
View Details
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