Brain Lesions After Transcatheter Aortic Valve Replacement
150 participantsStarted 2022-01
Plain-language 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.
Who can participate
Age range
60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The incidence of new brain microbleeds detected on MRI
Timeframe: Post-procedurally (up to 7 days) and 6 months
2
The incidence of new brain embolisms detected on MRI
Timeframe: Post-procedurally (up to 7 days) and 6 months