RecruitingOBSERVATIONAL

Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

This study is called the Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry. It focuses on a very rare heart problem that some babies are born with, where a valve in their heart (the tricuspid valve) doesn't form correctly. This condition, called Ebstein Anomaly or Tricuspid Valve Dysplasia, can be very serious for unborn babies. We currently don't know enough about how this condition affects babies, inside and outside the womb. This study aims to gather information from many different hospitals to help us understand how doctors make decisions and how babies with this condition get on. By learning more, we hope to improve the care and support available for affected babies and their families.

At a glance

Status

Recruiting

Sponsor

The Hospital for Sick Children

Enrolment target

1,500

Start

22 Sep 2021

Estimated completion

01 Sep 2055

Ebstein Anomaly Tricuspid Valve Dysplasia

What is this study about?

Imagine your heart has a special door, called a valve, that helps blood flow in the right direction. In babies with Ebstein Anomaly or Tricuspid Valve Dysplasia, this door, located on the right side of the heart, doesn't form properly. This can make it very hard for the heart to pump blood effectively, and it can be a serious problem for unborn babies.

Because this condition is so rare, doctors don't have enough information about it. Most of what we know comes from looking back at old patient records. This study is different because it will actively collect new information from pregnant mothers and their babies. By doing this across many different hospitals, we can build a much clearer picture of how this condition affects babies during pregnancy and after they are born.

The main goal is to understand how doctors decide on the best care for these babies and to see how the condition progresses. This knowledge will help improve the way future babies with Ebstein Anomaly are diagnosed, treated, and supported, ultimately aiming for better health outcomes for them and their families.

Key takeaways

It's a study about a rare heart condition in unborn babies.
The goal is to better understand Ebstein Anomaly and improve care.
Participation involves sharing existing medical information, no extra tests.
It helps doctors make better decisions for future babies.
You can stop participating at any time.

Who may be eligible?

This study is looking for pregnant mothers whose unborn baby has been diagnosed with Ebstein Anomaly or Tricuspid Valve Dysplasia. Your baby's heart should generally be otherwise normally formed, without other complex heart problems.

You can join the study at any point in your pregnancy, right up until the baby is born, or if the pregnancy sadly ends for other reasons. We can include single babies, as well as twins or triplets.

You wouldn't be able to join if your baby's heart has other very complex problems alongside Ebstein Anomaly, or if you're not able or willing to give your permission to take part.

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 unborn baby diagnosed with Ebstein Anomaly or Tricuspid Valve Dysplasia?
Does your baby's heart generally have normal connections, without other major heart defects?
Are you able to provide your agreement (consent) to take part?
Are you receiving care at a hospital involved in this study?

Answer every question to see your result.

What does participation involve?

Taking part in this study primarily involves allowing researchers to collect details about your baby's condition and your pregnancy journey. This information will come from your medical records at the hospital where you receive care. You won't need to take any new medication or undergo any extra tests just for the study.

The study aims to follow the progress of your baby through pregnancy and after birth. This means that if you choose to participate, the researchers will continue to collect information from your baby's medical records as they grow up. The total duration of your participation, and the follow-up, will involve looking at your medical notes from the time you join until after your baby is born, and potentially for several years afterwards, depending on how your baby's condition progresses. There are no additional hospital visits required specifically for this study.

Potential risks and benefits

There are no direct risks to you or your baby from participating in this study, as it only involves collecting information from your medical records. You won't undergo any extra or different procedures. The potential benefit is that by contributing your baby's information, you're helping doctors understand this rare condition much better, which could lead to improved care for future babies. You are free to withdraw your consent to participate at any time, for any reason, without affecting your or your baby's medical care.

Locations (1)

The Hospital for Sick Children
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is Ebstein Anomaly?

It's a rare heart problem where a valve on the right side of the heart doesn't form correctly, affecting blood flow.

Will my baby get different treatment if I join?

No, joining the study won't change the medical care your baby receives. It's about collecting information.

Do I need to do anything extra?

No, you don't need to do any extra tests or visits. The study gathers information from your existing medical notes.

Can I leave the study at any time?

Yes, you can choose to stop participating at any point, and it won't affect your medical care.

Who will see my information?

Your medical information will be kept private and used only by the research team for this study, helping to improve understanding of the condition.

How to find out more

Lindsay Freud, MD

lindsay.freud@sickkids.ca 416-813-7500 Official trial record

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