No registrations found.
ID
Source
Brief title
Health condition
aortic valve stenosis
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative to baseline) and cognitive functioning (extensive testing).
Secondary outcome
Regional differences in changes in CBF after TAVI (Δ ml/min/m3); Identify patient and procedural characteristics associated with increased cardiac output, CBF, white matter hyperintensity volume and cognitive functioning ; incidence and volume of new white matter hyperintensities after TAVI (number and volume mm3, relative increase %); aortic valve calcification volume (mm3), measured with computed tomography.
Background summary
Cognitive impairment is common (21-39%) among patients with severe aortic valve stenosis. The proof-of-concept CP-TAVI study showed increased cardiac output following transcatheter aortic valve implantation (TAVI) was associated with increased cerebral blood flow. We hypothesize increased cerebral blood flow (CBF) subsequently leads to improved cognitive functioning. Additionally, silent micro emboli caused by crushing of the calcified native valve during TAVI may cause cognitive deterioration. If it could be predicted which patients are at risk for TAVI induced cerebral micro emboli, these patients could benefit from cerebral protection devices, preventing cognitive decline. Therefore we assess 1A) whether an increase in cardiac output after TAVI is associated with an increase of global CBF; 1B) regional differences in CBF after TAVI; 1C) whether (global or regional) increased CBF is associated with improved cognitive functioning; 1D) patient and procedural characteristics associated with increased cardiac output, CBF and cognitive functioning; 2A) the incidence and volume of new white matter hyperintensities (WMH) after TAVI; 2B) patient and procedural predictors for the increase in WMH volume, including baseline aortic valve calcification volume, measured with computed tomography; 2C) if aortic valve calcification volume predicts new white matter hyperintensities, define a cut-off value for high-risk patients; 2D) assess whether the increase in white matter hyperintensity volume is associated with deterioration of cognitive scores. In a prospective observational cohort of 142 patients undergoing TAVI, we measure cardiac output using inert gas rebreathing; cerebral blood flow using arterial spin labelling MRI; and cognitive functioning using a neuropsychological test battery, prior to TAVI (<24 hours) and at 3 months follow-up.
Study objective
After TAVI, cardiac output will increase, which leads to increased cerebral blood flow (CBF) and subsequently to improved cognitive functioning. If it could be predicted which patients are at risk for TAVI induced cerebral micro emboli, these patients could benefit from cerebral protection devices, preventing cognitive decline.
Study design
Baseline (<24 hours before TAVI) and follow-up 3 months after TAVI
Intervention
Transcatheter aortic valve implantation (TAVI)
Inclusion criteria
Severe aortic valve stenosis (aortic valve area <1cm2 and/or mean aortic valve gradient exceeds 50 mmHg) of a native valve; able and willing to give informed consent; eligible for transfemoral TAVI, age > 18 years.
Exclusion criteria
Presence of MRI contra-indication; inability to lay flat for 30 minutes; weight > 130 kg; neurological presence; active malignant disease; insufficient mastery of the Dutch language; alcohol use inability to withdraw 24 hours; non-atherosclerotic vascular disease (eg vasculitis).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8721 |
| Other | METC AMC : METC 2019_08, NL72247.018.19 |