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)

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) - 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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000036810

Enrollment

315

Registered

2019-05-21

Start date

2019-05-17

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis (AS)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed as severe AS in echocardiography and scheduled for TAVI or SAVR at Hokkaido University Hospital. 2. Patients 20 years of age and older are eligible. 3. All patients receive from physicians the information necessary to give informed consent in writing.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactKiwamu Kamiya

Hokkaido University Faculty of Medicine Department of Cardiovascular Medicine

k-kamiya@med.hokudai.ac.jp011-706-6973

Outcome results