No registrations found.
ID
Source
Brief title
Health condition
Severe aortic valve stenosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increase of cerebral blood flow (mL blood/100g tissue /min) after TAVI
Secondary outcome
Incidence and volume of new white matter hyperintensities
Background summary
Despite the striking load of peri-procedural cerebral micro embolizations, cognitive functioning improves after transcatheter aortic valve replacement (TAVI). We hypothesize that the decreased cardiac output in patients with severe aortic valve stenosis leads to reduced cerebral blood flow which may be restored by TAVI. The objective of the current trial is to examine whether cerebral blood flow improves after TAVI. Moreover, predictors for an increase in cerebral blood flow will be evaluated. Fifty patients with severe aortic valve stenosis will undergo TAVI and prospective assessment of cerebral blood flow using arterial spin label magnetic resonance imaging (ASL-MRI) at baseline and 3 month follow-up. Moreover, the incidence of new white matter hyperintentsities will be evaluated. Finally, in a sub cohort, cerebral blood flow will be evaluated with transcranial Doppler (TCD) during rest, mild exercise and auto-regulation testing (cerebral blood flow in cm/s1).
Study objective
We hypothesize that the decreased cardiac output in patients with severe aortic valve stenosis leads to reduced cerebral blood flow in a subset of patients which may be restored by TAVI.
Study design
Measurements will be performed at two points in time: 1) Baseline (prior to TAVI), 2) 3 months after TAVI
Intervention
TAVI
Inclusion criteria
Patients with severe aortic valve stenosis, eligible for TAVI of a native valve
Exclusion criteria
History of cerebrovascular disease (eg. TIA, stroke)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL7495 |
CCMO | NL50524.018.14 |
OMON | NL-OMON44893 |