International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
This international study is collecting information from hospitals around the world about a specific treatment for young children (up to 3 years old) who have heart conditions. The treatment involves using a tiny plug, called a microvascular plug (MVP), to carefully control blood flow in the lungs. This is often done when the heart is working too hard because of too much blood flowing to the lungs. The study aims to understand how well these plugs work, if they are safe, and what happens to children after they have them fitted. It's collecting information on children who have already had this procedure, or will have it soon, to learn more about its real-world success.
At a glance
What is this study about?
This study is a bit like gathering information from a lot of different patient records across many hospitals, all around the world. It focuses on a special procedure where doctors use tiny plugs to control blood flow to the lungs in young children who have heart conditions. Sometimes, too much blood flows to the lungs, which can make the heart work too hard. These tiny plugs, called pulmonary flow restrictors, help to slow down this blood flow, taking some strain off the heart.
The main goal of this study is to see how successful this treatment is in real life. It looks at how safe the plugs are and how well they work to help children with their heart conditions. The doctors want to learn from what's already happened and what will happen in the future for children who have these plugs.
It's important to remember this isn't a study where doctors are trying a new, untested treatment. Instead, they are carefully observing and collecting information on a treatment that is already being used. This helps them understand the benefits and any challenges of using these plugs, so they can keep improving care for children with heart problems.
Key takeaways
- The study looks at tiny plugs used to control blood flow to the lungs in young children.
- It's collecting information from existing patient records worldwide to see how safe and effective this treatment is.
- Children up to 3 years old with certain heart conditions are included if they've had this specific procedure.
- There are no extra tests or treatments for children taking part; it's an observational study.
- The aim is to improve understanding and care for children with heart problems in the future.
Who may be eligible?
This study is looking for young children who have certain heart conditions and have had a specific procedure to help their heart.
To be included, a child must be aged 3 years or younger and have either a heart condition they were born with (congenital) or one they developed later. They must have had a special tiny plug, called a pulmonary flow restrictor, put into the blood vessels in their lungs. This procedure must have happened between January 2019 and January 2028. Lastly, a parent or legal guardian must agree for their child's information to be used in the study.
Children won't be included if their plug was put in a different part of the body, such as in certain shunts or ducts, rather than directly in the lung blood vessels. The study is open to children of any gender, background, or location as long as they meet the other criteria.
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 child 3 years old or younger?
- Does your child have a heart condition (either from birth or acquired later)?
- Has your child had a tiny plug (pulmonary flow restrictor) placed in the blood vessels of their lungs?
- Did this procedure happen between January 2019 and January 2028?
- Are you, as a parent or guardian, able to give your permission for their medical information to be used?
What does participation involve?
As this is an observational study, it means that if your child meets the criteria, the medical team will simply collect information from their existing medical records. This includes details about their heart condition, the procedure where they received the tiny lung plug, and how they are doing afterwards. There are no extra hospital visits, tests, or changes to your child's treatment plan specifically because of this study. Your child won't be given any new medication or asked to do anything different. The study gathers information from what is already happening as part of their routine care, both from past records and during future follow-up appointments they would have anyway. The total duration of data collection for each child will depend on when their procedure was done and how long the medical team continues to follow their progress as part of their usual care.
Potential risks and benefits
Locations (4)
- Marie Lannelongue HospitalVerified postcodeLe Plessis-Robinson, France
- Mother and Child Health Institute of SerbiaVerified postcodeBelgrade, Serbia
- Al Jalila Children's Specialty HospitalVerified postcodeDubai, United Arab Emirates
- Leeds Teaching Hospitals NHS TrustVerified postcodeLeeds, United Kingdom
Common questions
What is a 'pulmonary flow restrictor'?
It's a tiny plug used by doctors to carefully control the amount of blood flowing to a child's lungs when their heart needs less strain.
Is this study giving new treatment?
No, this study is simply observing and collecting information about a treatment that children have already received as part of their regular care.
Will my child need extra appointments?
No, your child will not need any extra hospital visits or tests because of this study. All information comes from their existing medical records.
Who is funding this study?
The information provided doesn't specify the funding source for this particular registry.
What happens with my child's personal information?
The study will collect medical information, but it will be handled carefully to protect your child's privacy, usually by removing any direct identifiers.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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