RecruitingOBSERVATIONAL

Effect of Fetal Aortic Valvuloplasty on Outcomes

This study is about a severe heart condition in unborn babies called Hypoplastic Left Heart Syndrome (HLHS), where the left side of the heart doesn't develop fully. This can happen if a valve in the baby's heart (the aortic valve) is too narrow. Some doctors try a procedure called fetal aortic balloon dilation to open this valve before birth. This study aims to find out if this treatment genuinely helps reduce the risk of HLHS, improves the baby's health in the long run, and what risks or side effects it might have for both mother and baby. We will compare babies who had this procedure with those who didn't.

At a glance

Status

Recruiting

Sponsor

Queen Silvia Children's Hospital, Gothenburg, Sweden

Enrolment target

200

Start

01 Jan 2021

Estimated completion

31 Dec 2029

Congenital Heart Disease Aortic Valve Stenosis Fetal Cardiac Disorder Hypoplastic Left Heart Syndrome

What is this study about?

Imagine your baby's heart is still growing in the womb, and sometimes, a crucial valve called the aortic valve, which helps blood flow out of the heart, can become too narrow. This narrowing can stop the left side of the baby's heart from developing properly, leading to a very serious condition called Hypoplastic Left Heart Syndrome (HLHS).

Doctors are exploring a treatment called fetal aortic balloon dilation. This is a procedure done while the baby is still in the womb, where a tiny balloon is used to gently open up that narrow aortic valve. The main goal of this study is to see if this procedure can actually prevent the left side of the heart from becoming underdeveloped and reduce the chances of the baby being born with HLHS. We also want to understand if this treatment leads to better health and quality of life for these children over time.

Another important part of this research is to carefully track any potential risks or side effects of the procedure for both the mother and the baby. By gathering this information, we hope to provide clear answers about whether this fetal treatment is effective and safe, helping doctors make the best decisions for future families facing similar challenges.

Key takeaways

This study evaluates a fetal heart procedure for a serious condition.
It aims to see if an early treatment can improve babies' heart development.
The research will also track any potential risks or side effects.
Participation will not change your medical care or add extra tests.
The study helps determine if this treatment is effective and safe.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, the unborn baby must be between 23 and 31 weeks old. During checks, doctors would find that the baby has a narrowed aortic valve, with blood flowing in a particular way through the heart, and the left side of their heart isn't working as strongly as it should.

Also, the baby's heart measurements, like the size of certain parts (left ventricle and mitral valve), need to be within specific ranges, as assessed by special ultrasound scans.

Families must also have access to specific heart operations for their baby after birth, including surgical or catheter-based treatments for the aortic valve, or more complex surgeries like Norwood or Ross-Konno. Babies would not be eligible if they have other serious heart problems or any other significant health issues or genetic conditions that might affect the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is your baby between 23 and 31 weeks gestational age?
Does your baby have a narrowed aortic valve with specific blood flow patterns?
Are your baby's heart measurements (left ventricle, mitral valve) within certain ranges on scan?
Do you have access to specific heart surgeries or procedures for your baby after birth?
Does your baby have no other significant heart problems or other serious health/genetic conditions?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't have any extra appointments or tests beyond what your doctors would normally recommend. This means the number of scans and check-ups for you and your baby during pregnancy, and for your baby after birth, will be the same whether you join the study or not. Your individual care and the treatment decisions made for your baby will not change because of your participation. We will simply collect information from your routine medical records and scans for the study. There are no specific medications involved in being part of the study; it's about observing outcomes.

Potential risks and benefits

The potential benefit of this research is helping to determine if fetal aortic balloon dilation is an effective and safe procedure that can potentially prevent a severe heart condition (HLHS) and improve health outcomes for babies. However, it's important to remember that this study is evaluating the procedure, and it's not yet proven to be effective. For those undergoing the treatment, there are expected risks associated with any medical procedure, which your doctor will discuss with you. Taking part in the study itself does not add extra procedures or change your care, meaning there are no additional study-related risks. You have the right to withdraw from the study at any time, without it affecting your medical care.

Locations (13)

Fetal Cardiovascular Program, University of California San Francisco
Verified postcode
San Francisco, United States· Recruiting
Congenital Heart Collaborative, Nationwide Children's Hospital
Verified postcode
Columbus, United States· Recruiting
Kinderherzzentrum Linz
Verified postcode
Linz, Austria· Recruiting
The Hospital for Sick Children Toronto
Verified postcode
Toronto, Canada· Recruiting
Department of Paediatric Cardiology, Helsinki University Children's Hospital
Verified postcode
Helsinki, Finland· Recruiting
Pediatric Cardiology - University Hospital Bonn
Verified postcode
Bonn, Germany· Recruiting
Department of Pediatric and Congenital Cardiology, University of Heidelberg
Verified postcode
Heidelberg, Germany· Recruiting
University hospital Technical university, mother- and-child center
Verified postcode
Munich, Germany· Recruiting
Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.
Verified postcode
Warsaw, Poland· Recruiting
Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre
Verified postcode
Madrid, Spain· Recruiting
Department of Pediatric Cardiology, Skane University Hospital
Verified postcode
Lund, Sweden· Recruiting
Department of pediatric cardiology, Karolinska Institute
Verified postcode
Stockholm, Sweden· Recruiting

Common questions

What is Hypoplastic Left Heart Syndrome (HLHS)?

HLHS is a severe condition where the left side of a baby's heart doesn't develop properly, making it hard for the heart to pump blood effectively.

What is fetal aortic balloon dilation?

It's a procedure done on an unborn baby to open a narrowed valve in their heart (the aortic valve) using a tiny balloon.

Will I have extra tests if I join the study?

No, you will not have any extra tests or appointments beyond what your doctors already recommend for your care and your baby's health.

Does taking part affect my baby's treatment?

No, your baby's medical care and treatment decisions, both during pregnancy and after birth, will not be influenced by whether you are in this study.

Can I leave the study if I change my mind?

Yes, you can decide to stop participating in the study at any point, and it will not affect the medical care you or your baby receive.

How to find out more

Mats Mellander, Dr, Prof

mats.mellander@vgregion.se 0046705530606 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.