Follow-up Study to Monitor the Efficacy and Safety of the Occlutech® mVSD Cases
This study is following people who have had a special device, called the Occlutech® mVSD Occluder, fitted to close a hole in their heart muscle. This hole is known as a muscular ventricular septal defect (mVSD). The main goals are to make sure the device works well and is safe for patients. Doctors will monitor participants over time using various checks like heart scans and blood tests. This will help them understand how the device performs in real-world use. The study is for people of all ages, from babies to older adults, who meet specific health requirements for this heart procedure.
At a glance
What is this study about?
This study is looking at a device called the Occlutech® mVSD Occluder. This device is designed to close a specific type of hole in the heart called a muscular ventricular septal defect (mVSD). A mVSD is a hole in the muscular wall that separates the two main pumping chambers of your heart. When this hole is significant, it can affect how your heart works.
The main purpose of this study is to check how well this device works and to make sure it's safe for patients. This is important because once a medical device is approved for use, studies like this help doctors and manufacturers understand its long-term effects and performance in many different people.
Researchers are collecting information from people who have already had this device fitted or will be getting it. They will follow these patients over several years to see if the device successfully closes the heart hole and if there are any problems. This information helps to confirm that the Occlutech® mVSD Occluder is a good and reliable treatment option for those who need it.
Key takeaways
- This study tracks the Occlutech® mVSD device for closing heart holes.
- It aims to confirm the device is both effective and safe over time.
- Patients will have regular health checks for up to 3 years.
- It is for people of various ages who need this heart procedure.
- Specialist heart doctors will carry out the procedure and checks.
- The study helps understand how the device works in real-life situations.
Who may be eligible?
You might be able to take part in this study if you have a muscular ventricular septal defect (a hole in your heart muscle) that needs closing, and your doctor thinks the Occlutech® mVSD device is suitable for you. This study is open to people of all ages, from 3 months old up to 80 years old, whether you are male or female. You would also need to understand what the study involves and agree to take part, and be able to attend follow-up appointments.
However, there are certain situations where you would not be able to join. For example, if you have certain active infections, allergies to materials in the device (like nickel or titanium), or if your heart condition is too severe in other ways, you might not be eligible. Also, if the hole in your heart muscle is too large (over 20mm) or too close to other important parts of your heart, the device 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 hole in the muscle wall of your heart that needs closing?
- Is your doctor recommending the Occlutech® mVSD device for you?
- Are you between 3 months and 80 years old?
- Are you able to attend several follow-up appointments over 3 years?
- Do you have any active infections or allergies to metals like nickel or titanium?
What does participation involve?
If you join this study, your treatment will follow the usual hospital procedures for fitting the Occlutech® mVSD device. The doctors performing the procedure are specialists in heart conditions and fitting these types of devices. After the device is put in, you will have several check-ups. These include a check within 48 hours, then again between 1 and 2 months, at 6 months, at 1 year, and finally at 3 years after your procedure. During these visits, doctors will check your heart using scans (like echocardiograms), take your blood pressure, do blood tests, and record your heart's electrical activity (ECG) to make sure the device is working well and you are healthy. You'll be treated according to standard care and how the device is meant to be used.
Potential risks and benefits
Locations (6)
- Children's Health IrelandVerified postcodeDublin, Ireland· Not yet recruiting
- İzmir Şehir HastanesiVerified postcodeIzmir, Turkey (Türkiye)· Not yet recruiting
- Eskişehir Osmangazi Üniversite HastanesiVerified postcodeEskişehir, Turkey (Türkiye)· Not yet recruiting
- Dicle Üniversitesi Tıp Fakültesi HastanesiVerified postcodeDiyarbakır, Turkey (Türkiye)· Not yet recruiting
- Gaziantep Unıversıty HospitalVerified postcodeGaziantep, Turkey (Türkiye)· Recruiting
- Royal Brompton HospitalVerified postcodeLondon, United Kingdom· Not yet recruiting
Common questions
What is a muscular ventricular septal defect (mVSD)?
It's a hole in the muscular wall that separates the two main pumping chambers of your heart.
What is the Occlutech® mVSD Occluder?
It's a special device designed to close this type of hole in your heart.
How long will I be followed up in this study?
You will have check-ups over a period of 3 years after the device is put in.
Are there age limits for this study?
Yes, people from 3 months old up to 80 years old can be considered.
Will I have to pay to be in the study?
No, you should not have to pay to participate in the study itself.
How to find out more
Ahmed Dellaa
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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