Brain Lesions After Transcatheter Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

Official title:

Brain Lesions After Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05065697
• Other study ID #: 2021V1
• Status: Not yet recruiting
• Start date: January 2022
• Est. completion date: January 2024

Study information

• Verified date: December 2021
• Source: West China Hospital
• Contact: Tian-Yuan Xiong, MBBS, PhD
• Phone: +86-028-85423582
• Email: xiongtianyuan[@]wchscu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 2024
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Brain Diseases

Intervention

Other:
• Brain MRI
Brain MRI will be scheduled within three days before the procedure and within seven days after the procedure, as well as at 1-year follow-up. MRI will be preferably performed using a 3.0-Tesla system unless patients are pacemaker-dependent after the procedure. In such case, a 1.5-Tesla system will be used. The MRI protocol consists of standardized conventional diffusion-weighted MRI (DW-MRI), T2-FLAIR (fluid-attenuated recovery inversion) and SWI (susceptibility-weighted imaging) parameters.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
West China Hospital	Rigshospitalet, Denmark, St Thomas' Hospital, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perfusion changes on transcranial doppler during TAVR or SAVR (if obtained)	Baseline perfusion will be obtained before femoral puncture in TAVR and the start of cardiopulmonary bypass in SAVR, until completion of eventual postimplantation maneuvers in TAVR and the stop of cardiopulmonary bypass in SAVR	Intra-procedurally
Primary	The incidence of new brain microbleeds detected on MRI	Microbleeds (including the number and size) on SWI after TAVR or SAVR during the index hospitalization and their evolution at the follow-up	Post-procedurally (up to 7 days) and 6 months
Primary	The incidence of new brain embolisms detected on MRI	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	Post-procedurally (up to 7 days) and 6 months
Secondary	Changes in the neurological and cognitive status of the patients (see description for specific assessments)	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.	Post-procedurally (up to 7 days), 6 months and 1 year