FetalFlow

Improved diagnosis of congenital heart disease in the fetus using novel multidimensional anatomical and blood flow cardiac MRI - FetalFlow

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON58580

Enrollment

Registered

2025-02-27

Start date

2027-07-01

Completion date

Unknown

Last updated

2026-05-18

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

Conditions

Congenital heart disease/defects, fetal heart abnormalities/anomalies Congenital heart defects

Interventions

The MRI sequences under investigation will utilize a MRI scanner software patch for PROspective Undersampling in multiple Dimensions (“PROUD”), previously developed at Amsterdam UMC. This allows for a

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal suspicion of significant CHD (significant CHD defined as requiring intervention within the first six months of postnatal life) based on prior fetal echocardiography Informed consent by the mother for fetal MRI and echo data, and by both parents for postnatal imaging/surgical findingsGestational age >28 weeks 

Exclusion criteria

Exclusion criteria: Maternal age <18 yearsContraindication for MR imaging (see Radiology department checklist: e.g. pacemaker, metallic implant, foreign body, claustrophobia)Inability to correctly inform mother about study due to language barrier or other factors 

Design outcomes

Primary

Measure	Time frame
This study aims to evaluate the additional diagnostic value of novel fetal-CMR sequences for the assessment of congenital heart disease (CHD) in third-trimester fetuses, compared with fetal echocardiography alone. To determine the additive value of an enhanced imaging protocol, two primary parameters will be assessed: (1) qualitative image assessment and (2) accuracy of associated prediction of postnatal diagnoses and outcomes.	—

Measure

Time frame

This study aims to evaluate the additional diagnostic value of novel fetal-CMR sequences for the assessment of congenital heart disease (CHD) in third-trimester fetuses, compared with fetal echocardiography alone. To determine the additive value of an enhanced imaging protocol, two primary parameters will be assessed: (1) qualitative image assessment and (2) accuracy of associated prediction of postnatal diagnoses and outcomes. 

—

Secondary

Measure	Time frame
To quantify CINE-derived cardiac values, including left and right ventricular stroke volumes at end of systole and diastole, ejection fraction and cardiac outputs, as well as the vena cavae, transverse and descending aortic and pulmonary diameters.To quantify blood flow, measured through developed 4D flow sequences, in clinically relevant vasculature (e.g. main pulmonary artery, aortic arch, ductal arch, descending aorta, inferior vena cava) and heart valves (e.g. aortic peak velocity and time to peak velocity).	—

Measure

Time frame

To quantify CINE-derived cardiac values, including left and right ventricular stroke volumes at end of systole and diastole, ejection fraction and cardiac outputs, as well as the vena cavae, transverse and descending aortic and pulmonary diameters.To quantify blood flow, measured through developed 4D flow sequences, in clinically relevant vasculature (e.g. main pulmonary artery, aortic arch, ductal arch, descending aorta, inferior vena cava) and heart valves (e.g. aortic peak velocity and time to peak velocity). 

—

Countries

Netherlands

Contacts

Public ContactPvO van Ooij

Amsterdam UMC

p.vanoiij@amsterdamumc.nl+31629299657

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: May 22, 2026