Cardiac output, cerebral perfusion and cognition in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation.
Completed
- Conditions
- aortic valve stenosiscerebral pefusion10046973
- Registration Number
- NL-OMON52941
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 152
Inclusion Criteria
• Presence of severe aortic valve stenosis (aortic valve area < 1 cm2 and/or
mean aortic valve gradients exceeds 50 mmHg) of a native valve
• Be able and willing of giving informed consent
• Eligible for transfemoral TAVI
• Age >18 years
Exclusion Criteria
• Presence of a magnetic resonance imaging (MRI) contra-indication.
• Orthopnea or inability to lay flat for 30 minutes
• Bodyweight >130 kg
• Neurological disease
• Insufficient mastery of the Dutch language
• Alcohol use >3 units per day or inability to withdraw 24 hours.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative<br /><br>to baseline) and cognitive functioning (extensive testing).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Regional differences in changes in CBF after TAVI (Δ ml/min/m3); Identify<br /><br>patient and procedural characteristics associated with increased cardiac<br /><br>output, CBF, white matter hyperintensity volume and cognitive functioning ;<br /><br>incidence and volume of new white matter hyperintensities after TAVI (number<br /><br>and volume mm3, relative increase %); aortic valve calcification volume (mm3),<br /><br>measured with computed tomography</p><br>