Study on postoperative prosthetic valve related complication prediction index by hemodynamics evaluation before and after aortic valve replacement in patients with severe aortic stenosis using time resolved 3D phase contrast MRI (4D flow MRI)
Not Applicable
Recruiting
- Conditions
- Aortic stenosis (AS)
- Registration Number
- JPRN-UMIN000036810
- Lead Sponsor
- Department of Cadiovascular Medicine, Hokkaido University Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 315
Inclusion Criteria
Not provided
Exclusion Criteria
Exclusion criteria in patient's eligibility are described below. 1. Patients unsuitable for MRI 2. Patients judged to be inappropriate as research subjects by the researcher
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to investigate the relationship between changes in blood flow dynamics (blood flow velocity, blood flow pattern, wall shear stress, energy loss) before and after TAVI or SAVR and structural valve degeneration and leaflet thrombosis
- Secondary Outcome Measures
Name Time Method The prespecified secondary outcomes of the study are described below. 1. To compare changes in blood flow dynamics before and after TAVI or SAVR between TAVI and SAVR groups 2. To investigate factors associated with changes in blood flow dynamics before and after TAVI or SAVR 3. To investigate the relationship between changes in blood flow dynamics before and after TAVI or SAVR and the composite of structural valve degeneration, leaflet thrombosis, rehospitalization due to heart failure, and death