REDUCE LAP-HF RANDOMIZED TRIAL I
This study is for people living with heart failure where the heart's pumping action is still quite good, but they continue to have symptoms. Researchers are testing a small device called the IASD® System II. This device is designed to create a tiny opening between the upper chambers of the heart to help relieve high pressure in the left side. The main goal is to see if this device is safe and effective in reducing this pressure, which might help people feel better. They will also look at how this affects general health and well-being over time. Participants will be carefully monitored throughout the study.
At a glance
What is this study about?
Imagine your heart acts like a pump, pushing blood around your body. In some people with heart failure, the left side of the heart, even if it pumps reasonably well, can develop too much pressure. This high pressure can lead to symptoms like breathlessness and tiredness.
This study is testing a special, small device called the IASD® System II. It's designed to be placed inside the heart to create a tiny passage between the two upper chambers. The idea behind this is to allow some of the high-pressure blood to move from the left side to the right side, hopefully reducing the overall pressure on the left side of the heart. The researchers want to find out if this device can safely and effectively lower this pressure and make people with heart failure feel better.
By carefully studying people who receive this device, the research team hopes to learn if it can improve their symptoms, how well they can exercise, and their overall quality of life. This could potentially offer a new treatment option for a specific group of heart failure patients who haven't found enough relief from standard medications.
Key takeaways
- Tests a new device for heart failure patients with high left-sided heart pressure.
- Aims to reduce symptoms by lowering pressure in the heart.
- Looks at safety and how well the device works.
- For people whose heart pumps reasonably well but still have symptoms.
- Not yet a standard treatment; it's still in the research phase.
Who may be eligible?
To join this study, you would typically need to be at least 40 years old and have ongoing symptoms of heart failure. Your heart's pumping ability (called 'ejection fraction') should be 40% or higher, and you should be taking the best available heart failure medications without getting enough relief from your symptoms. Doctors will also need to confirm that you have high pressure specifically in the left side of your heart during a special exercise test.
There are also some reasons why you might not be able to join. For example, if you've recently had a heart attack, heart surgery, or a procedure to unblock arteries in the past three months. You also wouldn't be able to join if you have very severe heart failure, certain heart valve problems, or if you've had a stroke or blood clots recently. If you are on dialysis or have very poor kidney function, you would also not be eligible.
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 40 years old or older?
- Do you have ongoing symptoms of heart failure despite taking your medications?
- Has a doctor told you your heart's pumping strength (ejection fraction) is 40% or more?
- Have you *not* had a recent heart attack, heart surgery, or stroke in the last 3-6 months?
- Are you able to walk at least 50 meters, but not more than 600 meters in 6 minutes?
- Are you currently not on dialysis or have very severe kidney problems?
What does participation involve?
If you decide to take part in this study, you would first go through screening tests to make sure you're a good fit. If you are, you would then have a procedure to implant the small device in your heart. This involves a minimally invasive procedure, similar to a stent insertion, guided by ultrasound from inside your heart. After the procedure, you would have regular follow-up appointments with the study team. These visits would involve checks of your heart and general health, physical exams, and tests like blood pressure measurements and sometimes exercise tests. The study team will explain all the details, including the number and frequency of visits, which may span a significant period to monitor long-term effects.
Potential risks and benefits
Locations (21)
- University of Arizona College of MedicineVerified postcodeTucson, United States
- Yale UniversityVerified postcodeNew Haven, United States
- Northwestern UniversityVerified postcodeChicago, United States
- Evanston Northshore HealthcareVerified postcodeEvanston, United States
- Cardiovascular Institute of the SouthVerified postcodeHouma, United States
- Ochsner Medical CenterVerified postcodeNew Orleans, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- University of Michigan Health SystemVerified postcodeAnn Arbor, United States
- Mayo ClinicVerified postcodeRochester, United States
- Columbia University Medical Center/NewYork Presbyterian HospitalVerified postcodeNew York, United States
- Mt. Sinai HospitalVerified postcodeNew York, United States
- New York UniversityVerified postcodeNew York, United States
Common questions
What is heart failure?
Heart failure means your heart isn't pumping blood as well as it should be, which can lead to tiredness and breathlessness.
What does the device do?
The IASD device creates a small opening between the heart's upper chambers to help lower high pressure on the left side.
Is this device approved for everyone?
No, this device is still being studied in clinical trials and is not yet a standard treatment.
How long does the study last?
The study involves initial procedures and then ongoing follow-up over a period that the study team will explain.
Will I feel better immediately?
If the device works, improvements in symptoms might happen gradually over time, but there's no guarantee.
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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