Brain Lesions After Transcatheter Aortic Valve Replacement

NCT ID: NCT05065697

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-31
• Study Completion Date: 2024-01-31

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.

Conditions

Aortic Valve Stenosis; Brain Diseases

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TAVR arm

Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices

Brain MRI

Intervention Type: OTHER

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.

SAVR arm

Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement

Brain MRI

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Neurological and cognitive assessments as recommended by NeuroARC

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St Thomas' Hospital, London

OTHER

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mao Chen

Director of Department of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Tian-Yuan Xiong, MBBS, PhD

Role: CONTACT

xiongtianyuan@wchscu.cn

+86-028-85423582

Other Identifiers

2021V1

Identifier Type: -

Identifier Source: org_study_id