Alleviant ALLAY-HF Study
This study, called ALLAY-HF, is for individuals living with heart failure, specifically those with 'HFpEF' or 'HFmrEF'. These are types of heart failure where the heart muscle is stiff or doesn't relax properly, leading to symptoms like breathlessness. The study is investigating a new treatment called the Alleviant ALV1 System. This system creates a small opening in the wall separating the upper chambers of the heart. The idea is that this opening might help reduce pressure in the heart, making it easier to breathe and improving overall well-being. This important research will compare the new device to a 'sham-control' where participants don't receive the active treatment, to understand if the Alleviant system genuinely makes a difference. Participants won't know if they've received the active device or the control, which helps ensure the results are fair and unbiased. The main goals are to find out if the device is safe and if it helps people feel better and live more comfortably.
At a glance
What is this study about?
Heart failure is a condition where your heart isn't pumping blood around your body as effectively as it should. This can make everyday activities difficult, causing symptoms like tiredness, shortness of breath, and swollen ankles. This particular study focuses on two specific types of heart failure: HFpEF (Heart Failure with preserved ejection fraction) and HFmrEF (Heart Failure with mildly reduced ejection fraction). In these types, the heart muscle might be stiff or unable to relax properly, even though it can still pump out a good amount of blood.
This study, called ALLAY-HF, is looking at a new device called the Alleviant ALV1 System. This system is designed to create a very small opening between the two upper chambers of your heart (called the atria). The aim of this small opening is to help relieve some of the pressure that can build up in the left side of your heart when it's not working well. By reducing this pressure, doctors hope it might ease your symptoms and improve how you feel overall.
Researchers want to see if the Alleviant ALV1 System is both safe to use and effective at helping people with HFpEF or HFmrEF. To do this, some participants will receive the Alleviant device, while others will have a 'sham-control' procedure, which is like a dummy treatment. This helps researchers fairly compare the new treatment to not having it, so they can be sure any improvements are really due to the device. The study is carefully designed to make sure no one, not even the doctors, knows who received which treatment, to ensure the results are accurate.
Key takeaways
- This study is for specific types of heart failure (HFpEF/HFmrEF).
- It's testing a new device (Alleviant ALV1) to relieve heart pressure.
- Participation involves either the device or a dummy procedure.
- The study aims to check safety and if it helps people feel better.
- Eligibility includes specific heart function and pressure measurements.
- You won't know if you get the active device or the sham.
Who may be eligible?
To be considered for this study, you would need to have certain types of heart failure called HFpEF or HFmrEF, meaning your heart's main pumping chamber is still working reasonably well (pumping at least 40% of its blood with each beat). You should also be experiencing symptoms of heart failure that affect your daily life, but not have very severe, advanced heart failure.
Another important check involves a special test called a "right heart catheterization" done during exercise. This test helps doctors understand the pressures inside your heart and lungs. For this study, it's important that this test shows high pressure in your left heart chamber during exercise, but that the blood flow in your lungs isn't too restricted. You also need to be on stable medication for your heart failure.
There are also some reasons why you might not be able to join. For instance, if your heart failure is very advanced, or if you already have a pacemaker fitted. Also, if there are signs that the right side of your heart isn't working properly, you wouldn't be eligible for this study.
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 heart failure where your heart still pumps at least 40% of its blood?
- Are you experiencing heart failure symptoms that affect your daily life?
- Do you have stable medication for your heart failure?
- Do you *not* have advanced heart failure or a pacemaker?
- Are you able to undergo an exercise test involving a heart tube insertion?
- Are you aged 40 or older?
What does participation involve?
If you join this study, you might receive the Alleviant ALV1 device or a sham procedure. Both procedures involve a small cut to insert a thin tube (catheter) into your heart. You won't know which you've received. You'll have several visits to the clinic for check-ups, which will include physical exams, heart scans (like echocardiograms), and tests to see how well you can exercise. You'll continue to take your usual heart medications throughout the study. The total duration of your participation, including follow-up appointments, will be explained specifically by the study team, but typically involves regular checks over several months to a year.
Potential risks and benefits
Locations (97)
- University of AlabamaVerified postcodeBirmingham, United States
- Arizona Cardiovascular Research CenterVerified postcodePhoenix, United States
- Pima Heart and VascularVerified postcodeTucson, United States
- Memorial Care Long Beach Medical CenterVerified postcodeLong Beach, United States
- UC Davis Medical CenterVerified postcodeSacramento, United States
- Scripps Clinical Research ServicesVerified postcodeSan Diego, United States
- San Francisco VAVerified postcodeSan Francisco, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Santa Barbara Cottage HospitalVerified postcodeSanta Barbara, United States
- Hartford HospitalVerified postcodeHartford, United States
- The Cardiac and Vascular Institute (TCAVI)Verified postcodeGainesville, United States
- HCA Florida Memorial HospitalVerified postcodeJacksonville, United States
Common questions
What is HFpEF/HFmrEF?
These are types of heart failure where your heart muscle is stiff or doesn't relax properly, making it harder for your heart to fill with blood, even if it can still pump it out quite well.
What is the Alleviant ALV1 System?
It's a small device that creates a tiny opening between the upper chambers of your heart. The aim is to reduce pressure inside the heart and help improve symptoms.
What does 'sham-controlled' mean?
It means some people will have the active procedure, and others will have a 'dummy' procedure that looks similar but doesn't involve the actual device. This helps make the study fair.
Will I know if I get the Alleviant device?
No, neither you nor your doctors will know if you received the active device or the sham procedure. This is done to make sure the results are accurate and unbiased.
What is a right heart catheterization?
It's a medical test where a thin, flexible tube is guided into your heart through a vein, usually in your neck or groin, to measure pressures and oxygen levels. For this study, it's done during exercise.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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