Cardiac output, cerebral perfusion and cognition in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantatio

Conditions: aortic valve stenosis

Registration Number: NL-OMON21148

Lead Sponsor: This study is supported by grants from the Dutch Heart Foundation (CVON Heart Brain Connection 2012-06 & 2018-28), Dutch Federation of University Medical Centres, the Netherlands Organisation for Health Research and Development and the Royal Nederlands Academy of Sciences.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 142

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).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac output (L/min), cerebral blood flow (mL/100g/min, change in %, relative to baseline) and cognitive functioning (extensive testing).

Secondary Outcome Measures

Name	Time	Method
Regional differences in changes in CBF after TAVI (? 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.