NCT05065697

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2021

Completed
26 days until next milestone

First Posted

Study publicly available on registry

October 4, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

1 year

First QC Date

September 8, 2021

Last Update Submit

December 27, 2021

Conditions

Aortic Valve StenosisBrain Diseases

Keywords

TAVRMagnetic resonance imagingIschemic infarctMicrobleeds

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • 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

Other Outcomes (1)

  • Perfusion changes on transcranial doppler during TAVR or SAVR (if obtained)

    Intra-procedurally

Study Arms (2)

TAVR arm

Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices

Other: Brain MRI

SAVR arm

Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement

Other: Brain MRI

Interventions

Brain MRIOTHER

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.

Also known as: Neurological and cognitive assessments as recommended by NeuroARC
SAVR armTAVR arm

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic severe aortic stenosis (\>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR at enrolling sites will be invited to participate in the study

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Aortic Valve StenosisBrain Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesVentricular Outflow ObstructionCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Tian-Yuan Xiong, MBBS, PhD

CONTACT

+86-028-85423582xiongtianyuan@wchscu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cardiology

Study Record Dates

First Submitted

September 8, 2021

First Posted

October 4, 2021

Study Start

January 1, 2022

Primary Completion

January 1, 2023

Study Completion

January 1, 2024

Last Updated

January 13, 2022

Record last verified: 2021-12