Not yet recruitingOBSERVATIONAL

An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects

This international study is gathering information about a medical procedure used to fix a specific type of hole in the heart called a perimembranous ventricular septal defect, often shortened to PmVSD. This hole is between the two main pumping chambers of the heart. The procedure involves using a special device, inserted without open-heart surgery, to close this hole. The study aims to understand how successful these procedures are in real-world situations, looking at different devices used in both children and adults. It will collect data from various hospitals to see how well patients recover and if the procedure is safe and effective over time.

At a glance

Status

Not yet recruiting

Sponsor

Fondation Hôpital Saint-Joseph

Enrolment target

1,000

Start

01 Mar 2025

Estimated completion

31 Jul 2026

Perimembranous Ventricular Septal Defect

What is this study about?

Imagine your heart as a house with four rooms. Sometimes, there can be a small hole in one of the walls that separates two of the main pumping rooms. This type of hole is called a perimembranous ventricular septal defect, or PmVSD. If this hole is large or causes problems, doctors might suggest closing it.

Traditionally, closing such a hole would involve open-heart surgery. However, there's a newer method called a 'transcatheter device closure'. This involves using a thin, flexible tube (a catheter) guided through a blood vessel to place a small device that plugs the hole, without needing major surgery. This study is like a large notebook where doctors from many different hospitals write down their experiences with this procedure.

The main goal of this study is to see how well this device closure method works in real patients – both children and adults – who have a PmVSD. They want to understand how safe it is, how effective different devices are, and what happens to patients over time after the procedure. By collecting this information, doctors can learn more about the best ways to treat PmVSDs and improve care for future patients.

Key takeaways

This study collects information about a non-surgical way to close heart holes.
It helps doctors understand how well different devices work in children and adults.
Participation means your medical information is used to improve future patient care.
You would receive standard care from your doctor; no experimental treatments are involved.
The study aims to gather real-world data on safety and effectiveness of the procedure.

Who may be eligible?

To be considered for this study, you would need to have a specific type of hole in your heart called a PmVSD, which has been confirmed by ultrasound scans. This hole should be between 3 millimetres and less than 20 millimetres in size. You would also need to be at least 3 months old and weigh at least 5 kilograms. You might be experiencing symptoms like heart failure, difficulty growing, repeated chest infections, or breathlessness, or your heart might be getting larger.

On the other hand, there are certain reasons why you might not be able to join the study. For example, if you have a very serious lung condition called Eisenmenger syndrome, or if you already have a complete heart block. They also can't include people with severe problems with other heart valves, or if you are pregnant or planning to be and the procedure involves X-rays. If you have active infections, uncontrolled bleeding issues, or other serious heart problems that would require surgery anyway, you might not be suitable.

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.

Do you have a PmVSD (a hole in your heart) confirmed by scan?
Is the hole size between 3mm and less than 20mm?
Are you 3 months old or older, and weigh at least 5 kg?
Do you *not* have a severe lung problem called Eisenmenger syndrome?
Do you *not* have severe issues with other heart valves needing surgery?

Answer every question to see your result.

What does participation involve?

This study is gathering information from patients who have already had or are planning to have a 'transcatheter device closure' for their PmVSD. This means you wouldn't be given a new or experimental treatment; rather, the study would observe your progress with a standard treatment. You wouldn't need extra visits just for the study beyond your usual check-ups, but the information from your medical records and follow-up appointments would be collected. There are no specific medications given just for the study, and your treatment would be decided by your own doctor. The study will look at your recovery and health over time following your procedure.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of PmVSD treatment, which could help improve care for future patients worldwide. However, there's no direct personal benefit from simply being part of the study itself, as it's observational. As with any medical procedure, there are potential risks associated with the transcatheter device closure, which your doctor will discuss with you. These risks are not caused by participating in the study but are part of the procedure itself. You are assured that your decision to participate or withdraw from the study at any time will not affect your medical care.

Locations (18)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Copenhagen University Hospital, Rigshospitalet
Verified postcode
Copenhagen, Denmark
University Hospital of Bordeaux
Verified postcode
Bordeaux, France
Marie Lannelongue Hospital
Verified postcode
Le Plessis-Robinson, France
Lille University Hospital
Verified postcode
Lille, France
Toulouse University Hospital
Verified postcode
Toulouse, France
University Children's Hospital
Verified postcode
Tübingen, Germany
National Cardiovascular Center of Harapan Kita
Verified postcode
Jakarta, Indonesia
Rajaie Cardiovascular, Medical and Research Center
Verified postcode
Tehran, Iran
Hôtel-Dieu de France University Medical Center
Verified postcode
Beirut, Lebanon
Hospital de Especialidades Pediátricas
Verified postcode
Chiapas, Mexico
The Children's Hospital
Verified postcode
Lahore, Pakistan
Silesian Center for Heart Diseases
Verified postcode
Zabrze, Poland

Common questions

What is a PmVSD?

A PmVSD is a specific type of hole in the wall (septum) that separates the two main pumping chambers of your heart.

What is 'transcatheter device closure'?

It's a way to close the hole in your heart using a special plug-like device inserted through a blood vessel, without needing open-heart surgery.

Will I get a new treatment if I join this study?

No, this study observes how current, standard treatments work. You would receive the treatment your doctor recommends, and the study would collect information about it.

Who can be in the study?

The study is for children and adults aged 3 months or older, with a PmVSD of a certain size, and who meet other specific medical criteria.

How long does participation last?

The study involves collecting information from your routine medical appointments over time after your procedure; you won't have extra visits just for the study.

How to find out more

Study Principal Investigator

raymondhaddad@live.com +33140942800 Official trial record

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