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Clinical Trial Summary

The Brain microblEeds after TrAnscatheter aorTic ValvE Replacement (BETTER) registry is a prospective, observational, multi-center registry aiming to assess the presence of new brain microbleeds assessed on susceptibility-weighted imaging at 3 enrolling sites, in China (West China Hospital, Sichuan University), UK (St Thomas' Hospital) and Denmark (Rigshospitalet, University of Copenhagen). The main study arm is planned to include 100 patients with symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices and 50 isolated bioprosthetic SAVR patients treated during the enrollment period as a control arm.


Clinical Trial Description

"Silent" stroke post-TAVR presents as asymptomatic brain ischemic lesions detected on diffusion-weighted magnetic resonance imaging (DW-MRI), with an incidence ranging from 60% to 100% in different studies. On the contrary, hemorrhagic lesions are not systematically studied given the poor visualization of small hemorrhage (i.e. microbleeds) on traditional T1, T2 or DW-MRI sequences. We have previously identified an incidence of new brain microbleeds early after TAVR of 100% with the routine use of susceptibility-weighted imaging (SWI). We hypothesize that new brain microbleeds are prevalent in patients with aortic stenosis after either TAVR or SAVR. The key objective of this registry is to evaluate the incidence, distribution and clinical impact of new brain microbleeds after transfemoral TAVR in patients with symptomatic severe aortic stenosis, in comparison with SAVR. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05065697
Study type Observational
Source West China Hospital
Contact Tian-Yuan Xiong, MBBS, PhD
Phone +86-028-85423582
Email [email protected]
Status Not yet recruiting
Phase
Start date January 2022
Completion date January 2024

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