Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This study is checking how safe and effective a device called the Occlutech® PDA Occluder is for closing a heart problem known as Patent Ductus Arteriosus (PDA). PDA is when a small blood vessel that’s normally open before birth doesn’t close properly afterward. The device helps seal this connection without major surgery. Researchers are looking back at previous cases and also following new patients who receive the device. They will check things like vital signs, heart rhythm (ECG), and heart scans (echocardiograms) at different times over up to three years to see how well the device works and if there are any problems. This will help make sure the treatment is safe and helpful for patients, especially children.
At a glance
What is this study about?
Imagine your heart is a house with many rooms and doors. Before you're born, there's a special temporary connection, like a shortcut, between two major blood vessels near your heart. This shortcut is called the Patent Ductus Arteriosus, or PDA. Normally, this shortcut closes soon after birth. But for some people, it stays open. If it stays open, it can make your heart work harder than it should, like leaving a door open between two important rooms when it should be closed.
This study is looking at a specific device called the Occlutech® PDA Occluder. Think of this device as a tiny plug designed to close that open shortcut. Instead of open-heart surgery, doctors can put this plug in using a thin tube (a catheter) inserted into a blood vessel, usually in the leg, and guide it to the heart. It's a less invasive way to fix the problem.
The researchers want to see how well this device works to close the PDA and how safe it is over time. They will be checking patients who've received this device for up to three years after it's put in. This helps them understand the long-term effects and ensure the device is a good and safe option for people with PDA.
Key takeaways
- This study evaluates a device for closing a heart condition called PDA.
- The device aims to fix PDA without the need for major surgery.
- Patients are followed for up to 3 years to check safety and effectiveness.
- Participation involves regular checks like heart scans and vital signs.
- The study helps improve future treatment options for PDA.
Who may be eligible?
To be part of this study, you or your child would generally need to have a Patent Ductus Arteriosus (PDA) that your doctor believes can be closed using the Occlutech PDA Occluder. This device is meant to close the PDA without needing major surgery. Patients usually need to weigh more than 3 kilograms (about 6.6 pounds).
There are some reasons why someone might not be able to join. For example, if the PDA is very small and not causing problems (a "silent ductus"), or if there's very serious high blood pressure in the lungs. Also, if there are known problems with blood clotting, existing infections in the heart lining, or allergies to certain metals (like nickel or titanium) or the dyes used in scans, you might not be eligible. If the blood vessels leading to the heart defect are too small for the equipment used, that would also prevent participation.
Crucially, you, or if you're a parent/guardian, you would need to understand what the study involves and agree for yourself or your child to take part. You also need to be able and willing to attend all the scheduled follow-up appointments.
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/your child have a heart condition called Patent Ductus Arteriosus (PDA)?
- Do you/your child weigh more than 3 kilograms (about 6.6 pounds)?
- Do you/your child NOT have very serious lung blood pressure or a serious active infection?
- Are you able and willing to attend follow-up visits for up to three years?
- Are you comfortable understanding and agreeing to the study requirements?
What does participation involve?
If you or your child take part in this study, doctors will first check your general health, including your vital signs (like heart rate and blood pressure), do an electrocardiogram (ECG) to check heart rhythm, and a heart scan called an echocardiogram to look at your heart and the PDA. These checks will happen before the device is put in, and again within 36 hours afterward.
After that, you'll have follow-up visits. These visits will usually include the same health checks (vital signs, ECG, echocardiograms) to see how well the device is working and if there are any issues. These follow-up visits will be scheduled at different times: between 1 and 3 months, then between 6 months and 1 year, then between 1 and 2 years, and finally between 2 and 3 years after the device was put in. The aim is to monitor your health and the device's performance over the long term.
Potential risks and benefits
Locations (15)
- CHU Sainte-JustineVerified postcodeMontreal, Canada· Not yet recruiting
- CHU de Lille - Institut Cœur-PoumonVerified postcodeLille, France· Not yet recruiting
- Hôpital Mère Enfant, CHU de NantesVerified postcodeNantes, France· Recruiting
- Children's Hospital Ireland at CrumlinVerified postcodeDublin, Ireland· Not yet recruiting
- Ospedale Pediatrico Bambino GesùVerified postcodeRoma, Italy· Recruiting
- Rawalpindi Institute of CardiologyVerified postcodeRawalpindi, Pakistan· Recruiting
- Children´s Hospital, Karolinska UniversityVerified postcodeStockholm, Sweden· Not yet recruiting
- Insel GruppeVerified postcodeBern, Switzerland· Not yet recruiting
- Hospital La RabtaVerified postcodeTunis, Tunisia· Recruiting
- Military HospitalVerified postcodeTunis, Tunisia· Recruiting
- Aydın Adnan Menderes University HospitalVerified postcodeAydin, Turkey (Türkiye)· Recruiting
- Eskişehir Osmangazi University HospitalVerified postcodeEskişehir, Turkey (Türkiye)· Recruiting
Common questions
What is Patent Ductus Arteriosus (PDA)?
It's a blood vessel that's open before birth but usually closes afterward. If it stays open, it's called a Patent Ductus Arteriosus.
What does the Occlutech® PDA Occluder do?
It's a special plug, put in using a thin tube, designed to close this open blood vessel in the heart without major surgery.
Will I or my child need surgery?
The goal of this device is to close the PDA without open-heart surgery, using a less invasive method with a thin tube (catheter).
How long will the follow-up appointments be?
You'll have several follow-up visits over a period of up to three years after the device is put in to check on your health and the device.
Can I stop participating in the study if I change my mind?
Yes, you have the right to withdraw from the study at any time, and it will not affect your medical care.
How to find out more
Ahmed Dellaa, PhD
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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