Brain Lesions After Transcatheter Aortic Valve Replacement

• Conditions: Aortic Valve Stenosis; Brain Diseases
• Interventions: Other: Brain MRI

• Registration Number: NCT05065697
• Lead Sponsor: West China Hospital

Brief Summary

The Brain lEsions 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.

Detailed 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 Timeline

• Study First Submitted: 2021-09-08
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-10-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-27
• Study Start: 2022-01
• Last Update Posted: 2022-01-13
• Primary Completion: 2023-01
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR

Exclusion Criteria

• Patients who have been diagnosed with brain cancer, brain haemorrhage, brain abscess, aneurysm, cerebral palsy, encephalitis, nervous system infection, head or neurological injury, or trauma, stroke
• Contraindications for a magnetic resonance imaging (MRI) scan (i.e. metallic implants, claustrophobia, MR-incompatible pacemakers or prosthetic heart valves)
• Unremovable dental prostheses that are deemed to affect MRI quality
• Severe coronary artery disease that is unrevascularized
• Prior stroke within the last 12 months
• Expected non-compliance concerning follow-up examinations
• Have participated in other clinical trials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAVR arm	Brain MRI	Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement
TAVR arm	Brain MRI	Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices

Primary Outcome Measures

Name	Time	Method
The incidence of new brain embolisms detected on MRI	Post-procedurally (up to 7 days) and 6 months	Ischemic infarcts (including the number and size) on DW-MRI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up
The incidence of new brain microbleeds detected on MRI	Post-procedurally (up to 7 days) and 6 months	Microbleeds (including the number and size) on SWI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up

Secondary Outcome Measures

Name	Time	Method
Changes in the neurological and cognitive status of the patients (see description for specific assessments)	Post-procedurally (up to 7 days), 6 months and 1 year	NIH Stroke Scale (NIHSS) and Montreal Cognitive Assessment (MoCA, cognitive impairment = score \<23/30) for overall cognitive status, and tests for five individual cognitive domains (Attention: Digit Symbol-Coding test \[DSST\]; Memory: Hopkins Verbal Learning Test-Revised \[HVLT-R\], Brief Visual Memory Test-Revised \[BVMT-R\]; Executive Function: Stroop Color-Word Association Test \[SCWT\], Category and Verbal Fluency \[both semantic and phonemic\]; Visuospatial Function: BVMT-R). The change of score in each assessment will be calculated.