All studies
Active not recruitingNAINTERVENTIONAL

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

Status
Active not recruiting
Phase
NA
Sponsor
Corvia Medical
Enrolment target
44
Start
01 Dec 2015
Estimated completion
01 Aug 2026

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.

  1. Are you 40 years old or older?
  2. Do you have ongoing symptoms of heart failure despite taking your medications?
  3. Has a doctor told you your heart's pumping strength (ejection fraction) is 40% or more?
  4. Have you *not* had a recent heart attack, heart surgery, or stroke in the last 3-6 months?
  5. Are you able to walk at least 50 meters, but not more than 600 meters in 6 minutes?
  6. Are you currently not on dialysis or have very severe kidney problems?
Answer every question to see your result.

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

Taking part in a study like this might offer a chance to try a new treatment that could potentially reduce your heart failure symptoms and improve your quality of life, especially if current medications aren't fully helping. However, as with any medical procedure, there are potential risks, including those associated with the device implantation itself, such as bleeding, infection, or issues related to the device. These will be fully explained by the study team. You are completely free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (21)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • University of Arizona College of Medicine
    Verified postcode
    Tucson, United States
  • Yale University
    Verified postcode
    New Haven, United States
  • Northwestern University
    Verified postcode
    Chicago, United States
  • Evanston Northshore Healthcare
    Verified postcode
    Evanston, United States
  • Cardiovascular Institute of the South
    Verified postcode
    Houma, United States
  • Ochsner Medical Center
    Verified postcode
    New Orleans, United States
  • Massachusetts General Hospital
    Verified postcode
    Boston, United States
  • University of Michigan Health System
    Verified postcode
    Ann Arbor, United States
  • Mayo Clinic
    Verified postcode
    Rochester, United States
  • Columbia University Medical Center/NewYork Presbyterian Hospital
    Verified postcode
    New York, United States
  • Mt. Sinai Hospital
    Verified postcode
    New York, United States
  • New York University
    Verified postcode
    New 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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