Aortic Valve StenosisNCT05065697
Brain Lesions After Transcatheter Aortic Valve Replacement
An observational study of Aortic Valve Stenosis and Brain Diseases, run by West China Hospital.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Brain Diseases
- What is being tested?
- Brain MRI
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Brain MRI
- Keywords
- TAVR, Magnetic resonance imaging, Ischemic infarct, Microbleeds
- Medical subject headings
- Aortic Valve Stenosis, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain MRIOther
Also called Neurological and cognitive assessments as recommended by NeuroARC
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.
| Study group | Role | What they receive |
|---|---|---|
| TAVR arm | Symptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices Receives: Other: Brain MRI | |
| SAVR arm | Symptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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)
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.
Measured: Post-procedurally (up to 7 days), 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St Thomas' Hospital, London, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Mao Chen, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065697
- Sponsor's protocol ID
- 2021V1
- Status last verified
- Dec 2021
- First submitted
- 8 Sep 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Lesions After Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT05065697
- Acronym / sponsor ID
- 2021V1
- Conditions
- Aortic Valve Stenosis, Brain Diseases
- Keywords
- TAVR, Magnetic resonance imaging, Ischemic infarct, Microbleeds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Collaborators
- St Thomas' Hospital, London, Copenhagen University Hospital, Rigshospitalet
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVR arm | – | Other: Brain MRISymptomatic severe aortic stenosis undergoing transfemoral TAVR of any devices |
| SAVR arm | – | Other: Brain MRISymptomatic severe aortic stenosis undergoing isolated bioprosthetic surgical aortic valve replacement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Symptomatic severe aortic stenosis (>60 years old) being scheduled for either transfemoral TAVR or isolated SAVR
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain MRIAlso: Neurological and cognitive assessments as recommended by NeuroARCBrain 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. | Other | SAVR arm, TAVR arm |
Primary outcome
The incidence of new brain microbleeds detected on MRI
Time frame: 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
The incidence of new brain embolisms detected on MRI
Time frame: 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
1 secondary outcome
Changes in the neurological and cognitive status of the patients (see description for specific assessments)
Time frame: Post-procedurally (up to 7 days), 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis and Brain Diseases, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tian-Yuan Xiong, MBBS, PhD (+86-028-85423582, xiongtianyuan@wchscu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of new brain microbleeds detected on MRI (time frame: Post-procedurally (up to 7 days) and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.