Clinical trial NCT05065697: Brain Lesions After Transcatheter Aortic Valve Replacement
Official title: Brain Lesions After Transcatheter Aortic Valve Replacement
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Valve Stenosis
Brain Diseases
Keywords: TAVR
Magnetic resonance imaging
Ischemic infarct
Microbleeds
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: St Thomas' Hospital, London
name: Rigshospitalet, Denmark
First posted: 2021-10-04
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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.

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

Primary outcomes:
measure: The incidence of new brain microbleeds detected on MRI
timeFrame: Post-procedurally (up to 7 days) and 6 months
measure: The incidence of new brain embolisms detected on MRI
timeFrame: Post-procedurally (up to 7 days) and 6 months
Secondary outcomes:
measure: Changes in the neurological and cognitive status of the patients (see description for specific assessments)
timeFrame: Post-procedurally (up to 7 days), 6 months and 1 year
Other outcomes:
measure: Perfusion changes on transcranial doppler during TAVR or SAVR (if obtained)
timeFrame: Intra-procedurally
Locations:
Study officials:
References: