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European Multicentre Registry of Percutaneous Paravalvular Leak Closure

This study is gathering information about a special keyhole procedure (without open surgery) used to fix leaks around replacement heart valves. These leaks can sometimes happen after a valve operation and can cause problems like tiredness or breathlessness. The procedure aims to seal these leaks. We want to understand how successful this treatment is, if it helps patients feel better, and if it improves their quality of life. Even a small improvement in the leak might make a big difference to how people feel. This study is for people aged 16 and over who are already having this procedure, and it will follow their progress over time.

At a glance

Status
Recruiting
Sponsor
Centre Chirurgical Marie Lannelongue
Enrolment target
400
Start
01 Jan 2020
Estimated completion
01 Jul 2026

What is this study about?

When someone has a heart valve replaced, either through surgery or a less invasive keyhole procedure, sometimes a small leak can form around the edge of the new valve. This is called a 'paravalvular leak'. These leaks can sometimes cause health problems like tiredness, breathlessness, or even needing blood transfusions. For many years, surgery was the only way to fix these leaks. However, for some people, especially those who are already quite unwell, open-heart surgery can be too risky.

Because of this, doctors have developed a keyhole procedure to try and close these leaks without needing major surgery. This involves using thin tubes (catheters) to guide tiny devices to the leak and seal it. While this procedure has become better over time with improved tools and more experienced doctors, we still need more information about how well it works for patients in the long term, and critically, how it affects their daily lives and overall health.

This study aims to collect detailed information from many hospitals across Europe about this keyhole procedure. We want to find out how successful the procedure is, how safe it is, and whether it truly makes a difference to patients' symptoms and their quality of life. We believe that even a small reduction in the leak could lead to big improvements in how patients feel, such as having more energy and less breathlessness. By gathering this information, we hope to improve care for people with these types of heart valve leaks.

Key takeaways

  • This study focuses on a keyhole procedure to fix leaky heart valves.
  • It aims to understand how well the procedure works and if it improves patients' lives.
  • Data will be collected from people aged 16 and over who are already having this treatment.
  • The study will follow patients for up to two years to see long-term effects.
  • Taking part helps improve future care for patients with similar heart conditions.

Who may be eligible?

To be part of this study, you need to be aged 16 or older and be referred for a keyhole procedure to fix a paravalvular leak around your heart valve. The study is collecting information on people who are already having this treatment, rather than testing a brand new one.

We need your agreement to use your health information for the study. If you're under 16, or if you or your parent/guardian (if you're a minor) don't want to take part, then you won't be included in this study.

Essentially, if you're an adult aged 16 or over and your doctor has decided that a keyhole procedure is the right treatment for your leaky heart valve, and you're happy for your information to be used for research, you'll likely be eligible.

Quick self-check
  • Are you 16 years old or older?
  • Has your doctor referred you for a keyhole procedure to fix a leak around your heart valve?
  • Are you happy for information about your health and treatment to be used for research?
  • Do you understand that you can change your mind about taking part at any time?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, it means that information about your leak-fixing procedure and your health will be collected for this study. Before your keyhole procedure, you'll answer some questions about your quality of life. Your doctor will then carry out the procedure as planned. After your procedure, at about three months, you'll be asked to answer the quality of life questions again. Doctors will also check how things are going with your heart and collect information on your health for up to two years. This helps us understand the long-term effects of the treatment and how you feel over time. There are no extra visits just for the study; all information is gathered during your usual hospital appointments.

Potential risks and benefits

Taking part in this study won't change your medical treatment—you'll receive the care your doctor recommends. The main benefit is helping us learn more about this procedure, which could improve care for future patients with similar heart problems. There are no direct benefits or risks to you from simply being part of the study, as it only involves collecting information from your existing medical care. The procedure itself carries some risks, which your doctor will discuss with you. You are free to withdraw your consent for your information to be used in the study at any time without affecting your medical treatment.

Locations (33)

  • CHU Charleroi
    Charleroi, Belgium· Recruiting
  • Podlesi hospital
    Třinec, Czechia· Recruiting
  • CHU Amiens
    Amiens, France· Recruiting
  • Hopital d Annecy
    Annecy, France· Recruiting
  • CHU Henri Mondor
    Créteil, France· Recruiting
  • CHU Grenoble
    Grenoble, France· Recruiting
  • centre chirurgical Marie Lannelongue
    Le Plessis-Robinson, France· Recruiting
  • Hopital Prive Brabois
    Lille, France· Recruiting
  • CHU La Timone
    Marseille, France· Recruiting
  • Hopital Europeen
    Marseille, France· Recruiting
  • Hopital Prive Clairval
    Marseille, France· Recruiting
  • CHU Nancy
    Nancy, France· Recruiting

+21 more sites — see the official record for the full list.

Common questions

What is a 'paravalvular leak'?

It's a small leak that sometimes forms around the edges of a replacement heart valve after it's been put in.

What is the 'keyhole procedure' you mention?

It's a way to fix the leak using thin tubes and devices guided through blood vessels, without needing open-heart surgery.

Will my treatment be different if I join this study?

No, you will receive the exact same treatment and care your doctor recommends, whether you join the study or not.

How to find out more

Sebastien Hascoet, MD, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "European Multicentre Registry of Percutaneous Paravalvular L…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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