NCT05386173 Effect of Fetal Aortic Valvuloplasty on Outcomes
| NCT ID | NCT05386173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Queen Silvia Children's Hospital, Gothenburg, Sweden |
| Condition | Congenital Heart Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective. The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.
Eligibility Criteria
Inclusion Criteria: A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al): 1. Aortic valve stenosis with antegrade flow through the valve 2. Predominantly left-to-right shunt at the atrial level 3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels 4. Qualitatively depressed left ventricular function 5. Left ventricular end-diastolic diameter Z-score \> ±0 6. Left ventricular inlet length in diastole : 1. Gestational age ≤ 24+6: Z-score \> ±0 2. Gestational age 25+0 to 27+6: Z-score \> -0.75 3. Gestational age ≥ 28+0: Z-score \> -1.50 7. Mitral valve diameter in diastole Z-score \> -2.0 B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery Exclusion Criteria: 1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta 2. Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05386173 clinical trial?
This trial is open to participants of all sexes, aged 23 Weeks or older, up to 31 Weeks, studying Congenital Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05386173 currently recruiting?
Yes, NCT05386173 is actively recruiting participants. Contact the research team at mats.mellander@vgregion.se for enrollment information.
Where is the NCT05386173 trial being conducted?
This trial is being conducted at San Francisco, United States, Columbus, United States, Linz, Austria, Toronto, Canada and 9 additional locations.
Who is sponsoring the NCT05386173 clinical trial?
NCT05386173 is sponsored by Queen Silvia Children's Hospital, Gothenburg, Sweden. The trial plans to enroll 200 participants.