Evaluating fetal aortic valve balloon dilation for congenital heart defects
Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
This study is testing whether a procedure called fetal aortic valvuloplasty can help fetuses with aortic valve problems caused by hypoplastic left heart syndrome feel better and have better outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 23 Weeks to 31 Weeks |
| Sex | All |
| Sponsor | Queen Silvia Children's Hospital, Gothenburg, Sweden Academic / other |
| Locations | 13 sites (San Francisco, California and 12 other locations) |
| Trial ID | NCT05386173 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of fetal aortic valvuloplasty in treating aortic valve stenosis in fetuses diagnosed with hypoplastic left heart syndrome (HLHS). It will collect and analyze pre- and postnatal clinical data, including echocardiographic examinations, to compare outcomes between fetuses receiving the intervention and those who do not. The study will also investigate potential side effects and risks associated with the procedure for both the fetus and the mother. The decision to perform the balloon dilation is independent of the study protocol, ensuring standard care is maintained for all participants.
Who should consider this trial
Good fit: Ideal candidates are fetuses diagnosed with aortic valve stenosis and HLHS, meeting specific echocardiographic criteria during the gestational period.
Not a fit: Patients with associated cardiac defects or those not meeting the echocardiographic criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the development of the left ventricle and overall prognosis for infants with HLHS.
How similar studies have performed: While balloon dilation has been used in some centers, there is limited scientific evidence supporting its effectiveness, making this study a critical evaluation of an untested approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Francisco, California and 12 other locations
- Fetal Cardiovascular Program, University of California San Francisco — San Francisco, California, United States (Recruiting)
- Congenital Heart Collaborative, Nationwide Children's Hospital — Columbus, Ohio, United States (Recruiting)
- Kinderherzzentrum Linz — Linz, Austria (Recruiting)
- The Hospital for Sick Children Toronto — Toronto, Canada (Recruiting)
- Department of Paediatric Cardiology, Helsinki University Children's Hospital — Helsinki, Finland (Recruiting)
- Pediatric Cardiology - University Hospital Bonn — Bonn, Germany (Recruiting)
- Department of Pediatric and Congenital Cardiology, University of Heidelberg — Heidelberg, Germany (Recruiting)
- University hospital Technical university, mother- and-child center — Munich, Germany (Recruiting)
- Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education. — Warsaw, Poland (Recruiting)
- Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre — Madrid, Spain (Recruiting)
- Department of Pediatric Cardiology, Skane University Hospital — Lund, Sweden (Recruiting)
- Department of pediatric cardiology, Karolinska Institute — Stockholm, Sweden (Recruiting)
- Department of Pediatrics, Umeå University Hospital — Umeå, Sweden (Recruiting)
Study contacts
- Study coordinator: Mats Mellander, Dr, Prof
- Email: mats.mellander@vgregion.se
- Phone: 0046705530606
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.