Hemodynamic characterization of the respect and resect approaches in mitral valve repair surgery: a 4D-flow MRI study (RES-P-ECT 4D trial)

Hemodynamic characterization of the respect and resect approaches in mitral valve repair surgery: a 4D-flow MRI study (RES-P-ECT 4D trial) - 4D flow after surgical respect or resect approach (RES-P-ECT 4D trial)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53892

Enrollment

Registered

2023-03-22

Start date

2023-10-01

Completion date

Unknown

Last updated

2024-10-07

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

Conditions

heart valve leakage Mitral valve regurgitation

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients who have undergone surgical mitral valve repair - more than 1 year ago - for mitral regurgitation due to a prolapse of the P2 leaflet segment of the mitral valve.

Exclusion criteria

Exclusion criteria: - Have underwent a cardiac reoperation after the initial mitral valve repair procedure - Have major comorbidity besides mitral regurgitation - Are under the age of 18. - Have claustrophobia or another contra-indication for MRI. - Are not able to provide written informed consent.

Design outcomes

Primary

Measure	Time frame
The main study parameters are; - blood flow velocity (kinetic energy and turbulent kinetic energy) in the left atrium, left ventricle, over the aortic valve, in the ascending aorta, the aortic arch and the descending aorta - energy loss in the left atrium, left ventricle, over the aortic valve, in the ascending aorta, the aortic arch and the descending aorta - trans-valvular flow quantification of the mitral valve All outcomes will be compared to available reference values in healthy subjects.	—

Measure

Time frame

The main study parameters are; - blood flow velocity (kinetic energy and turbulent kinetic energy) in the left atrium, left ventricle, over the aortic valve, in the ascending aorta, the aortic arch and the descending aorta - energy loss in the left atrium, left ventricle, over the aortic valve, in the ascending aorta, the aortic arch and the descending aorta - trans-valvular flow quantification of the mitral valve All outcomes will be compared to available reference values in healthy subjects.

—

Secondary

Measure	Time frame
Routine MRI parameters; - enddiastolic and endsystolic volumes - stroke volume - ejection fraction	—

Countries

Netherlands

Outcome results