REDUCE LAP-HF III Corvia Protocol 1701
This study is for people in Germany who have heart failure and are being treated with a new device called the IASD System II. This device has already been approved for use in the EU. Instead of a typical clinical trial, this is like a long-term check-up to see how the device performs after people have received it. Researchers will collect information from patients about how well the treatment is working for them, if they experience any problems, and if their quality of life has improved. The main goal is to understand how this new treatment works in real-life situations, helping doctors learn more about managing heart failure.
At a glance
What is this study about?
Imagine your heart is a pump, and with heart failure, it's not pumping quite as well as it should. This can make you feel tired or short of breath because your body isn't getting enough blood. Doctors are always looking for new ways to help people with heart failure feel better and live fuller lives.
This particular study is not like a typical experiment. Instead, it's a way for doctors to keep an eye on a new treatment called the IASD System II after it's already been approved for use in Europe. Think of it like a follow-up survey for new technology. The goal is to gather information from people who have already had this device implanted as part of their regular care.
The main purpose is to see how well the IASD System II works in real-world settings. Doctors want to understand if it helps people feel better, if it's safe, and if it genuinely improves their quality of life over time. By carefully collecting this information, they can learn more about how this new treatment helps people with heart failure.
Key takeaways
- This study collects real-world data on a heart failure device.
- It aims to understand device safety, effectiveness, and quality of life.
- Participants have already received the IASD System II device.
- The study takes place in Germany.
- It helps doctors learn more about this heart failure treatment.
Who may be eligible?
This study is gathering information on people who have already been treated with a device called the IASD System II for their heart failure. It's not a study where you would sign up to get a new treatment; it's for people who have already received it.
Generally, participants will be 40 years old or older. The study is open to both men and women. The treatments are being given in medical centres in Germany.
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.
- Are you currently receiving treatment with the IASD System II for heart failure?
- Are you 40 years old or older?
- Are you being treated at a medical centre in Germany?
- Are you happy for information from your regular medical check-ups to be shared with researchers?
What does participation involve?
If you are already receiving the IASD System II device in Germany, your doctor might ask if you would be willing to share information about your health with researchers. Taking part would mostly involve allowing your medical team to collect details from your regular check-ups. This includes information about how you're feeling, how well the device is working, and any health changes you experience. There aren't any extra visits or medications specifically for the study. The actual duration of your participation would depend on how long your doctor plans to monitor your condition, as this is part of your ongoing care.
Potential risks and benefits
Locations (27)
- Herzzentrum der Kerckhoff-KlinikVerified postcodeBad Nauheim, Germany
- Herz- und Diabeteszentrum Nordrhein-Westfalen Klinik für KardiologieVerified postcodeBad Oeynhausen, Germany
- Segeberger Kliniken GmbHVerified postcodeBad Segeberg, Germany
- Unfallkrankenhaus BerlinVerified postcodeBerlin, Germany
- Klinikum Chemnitz gGmbHVerified postcodeChemnitz, Germany
- Herzzentrum der Universität zu KölnVerified postcodeCologne, Germany
- Klinikum Lippe GmbHVerified postcodeDetmold, Germany
- Herzzentrum Dresden GmbHVerified postcodeDresden, Germany
- Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie u. AngiologieVerified postcodeDüsseldorf, Germany
- Elisabeth-Krankenhaus EssenVerified postcodeEssen, Germany
- Universitätsklinikum GießenVerified postcodeGiessen, Germany
- Universitätsklinikum GöttingenVerified postcodeGöttingen, Germany
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as effectively as it should. It doesn't mean your heart has stopped working, but it can make you feel tired and short of breath.
What is the IASD System II?
It's a medical device that has been approved for use in the EU to help people with heart failure. This study is looking at how well it works in real life.
Do I get the treatment if I join this study?
No, this study is for people who have already received the IASD System II as part of their medical care. You won't receive new treatment just by joining the study.
Where is this study taking place?
This study is being carried out in medical centres across Germany.
What does 'observational registry' mean?
It means doctors are collecting information on patients who are already receiving a treatment, without giving them specific instructions or new interventions just for the study. They are observing how things happen naturally.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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