Safety and feasibility study of fetal cardiac intervention for critical aortic stenosis

Safety and feasibility study of fetal cardiac intervention for critical aortic stenosis - Feasibility study of fetal intervention for critical aortic stenosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036649

Enrollment

Registered

2019-05-08

Start date

2019-04-01

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

critical aortic stenosis

Interventions

Fetal aortic valvuloplasty for critical aortic stenosis

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: [Maternal criteria] Between 22+0 and 31+6 weeks gestation Pregnant women who have no severe complication or symptom of preterm labor [Fetal criteria] Fetal critical aortic stenosis without small left ventricle Z score of LV long-axis dimension >-2 Threshold score 4 or 5 No other severe anomalies

Exclusion criteria

Exclusion criteria: Pregnant women who have infectious diseases required treatments Pregnant women who have severe psychological disorder American Society of Anesthesiology (ASA) Physical Status Classification Class 3, 4, 5 or 6 Multiple pregnancy Severe obesity (BMI >35)

Design outcomes

Primary

Measure	Time frame
The rates of completing protocol therapy without severe adverse events	—

Secondary

Measure	Time frame
The number and grade of adverse events by protocol therapy	—

Countries

Japan

Contacts

Public ContactSeiji Wada

National Center for Child Health and Development Division of Fetal Medicine

wada-s@ncchd.go.jp03-3416-0181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026