Alleviant ALLAY-HFrEF Study
The Alleviant ALLAY-HFrEF Study is looking into a new way to help people with a type of heart failure where their heart doesn't pump blood strongly enough. This trial uses a device called the Alleviant ALV1 System to create a small, permanent opening between the two upper chambers of the heart. The idea is that this might reduce pressure in the heart and improve symptoms. Patients will be randomly put into two groups: one receiving the Alleviant ALV1 System and another receiving a ‘sham’ treatment, which is like a fake procedure. This helps researchers fairly compare the new treatment's safety and how well it works.
At a glance
What is this study about?
Heart failure is a condition where your heart can't pump enough blood around your body to meet its needs. This can make you feel tired, breathless, and swollen. There are different types of heart failure, and this study focuses on a type called Heart Failure with Reduced Ejection Fraction (HFrEF), which means the heart's main pumping chamber isn't squeezing as strongly as it should.
This study, called the Alleviant ALLAY-HFrEF Study, is looking at a new treatment called the Alleviant ALV1 System. The system creates a tiny, permanent opening between the two upper chambers of your heart. The aim is to lower the pressure inside the heart, which might help ease symptoms and improve your quality of life. This is a "randomized, sham-controlled" study, meaning some participants will get the actual treatment, and others will get a 'sham' procedure that mimics the treatment but doesn't actually create the opening. Neither you nor your doctor will know which group you are in, so the results can be judged fairly.
The researchers want to find out if this new device is safe and effective for people with HFrEF. If successful, it could offer another treatment option for managing this type of heart failure. It's important to remember that this is a research study, and the benefits and risks are still being investigated.
Key takeaways
- Investigating a new device for a specific type of heart failure.
- Aims to reduce heart pressure for symptom improvement.
- Involves a procedure to create a small opening in the heart.
- Compares the new treatment to a 'sham' (inactive) procedure.
- Participation requires ongoing use of existing heart medications.
Who may be eligible?
To join this study, people generally need to be adults, aged 18 or older. They must have a specific type of heart failure where their heart's main pumping chamber (left ventricle) isn't working as well as it should, meaning it pumps out 40% or less of the blood it contains with each beat. They also need to be experiencing symptoms that affect their daily life, ranging from mild to more significant, and already be on the best possible medical treatments for heart failure, which they are taking regularly.
There are also some reasons why you might not be able to join. For example, if your heart failure is very advanced or if doctors believe you have less than a year to live, this study wouldn't be suitable. Additionally, if there are signs your heart's right-hand side isn't working properly, or if there are other severe health issues, you might not be able to participate. The study will also exclude people who are generally too unwell to take part safely.
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 18 years old or older?
- Has your doctor told you that your heart's main pumping chamber is pumping 40% or less of the blood it contains?
- Are you experiencing symptoms of heart failure (like breathlessness or tiredness) that affect your daily life?
- Are you currently taking your heart failure medications as prescribed and in stable doses?
- Is your current health stable, and do doctors expect you to live for more than 12 months?
What does participation involve?
If you decide to take part in this study, you will have several visits to the hospital for checks and tests. This might include heart scans, blood tests, and assessments of your symptoms. The main part of the study involves a procedure where the Alleviant ALV1 System is either implanted or you receive a 'sham' procedure. This procedure is done by inserting a thin tube (catheter) into a blood vessel, usually in your leg, and guiding it to your heart. It typically involves a short hospital stay.
After the procedure, you will have regular follow-up appointments over a period, which will involve further examinations to see how you are doing, how your heart is working, and if there are any side effects. You will continue to take your regular heart failure medications as prescribed by your doctor throughout the study. The total duration of your participation in the study, including all follow-up appointments, will be explained in detail by the study team.
Potential risks and benefits
Locations (61)
- Keck Medical Center of USCVerified postcodeLos Angeles, United States
- UC Davis Medical CenterVerified postcodeSacramento, United States
- Scripps Clinical Research ServicesVerified postcodeSan Diego, United States
- University of California San FranciscoVerified postcodeSan Francisco, United States
- Delray Medical CenterVerified postcodeDelray Beach, United States
- Ascension Sacred HeartVerified postcodePensacola, United States
- Tampa General HospitalVerified postcodeTampa, United States
- Atlanta VA Health Care SystemVerified postcodeDecatur, United States
- Midwest Cardiovascular InstituteVerified postcodeNaperville, United States
- Cardiovascular Institute of the SouthVerified postcodeHouma, United States
- University Medical Center New OrleansVerified postcodeNew Orleans, United States
- Tufts Medical CenterVerified postcodeBoston, United States
Common questions
What is Heart Failure with Reduced Ejection Fraction (HFrEF)?
HFrEF is a type of heart failure where your heart's main pumping chamber can't pump enough blood to meet your body's needs because it's too weak.
What is the Alleviant ALV1 System?
It's a new device being tested that creates a small, permanent opening between the upper chambers of your heart to try and reduce pressure.
What does 'sham-controlled' mean?
It means some people will have the actual procedure, and others will have a 'fake' procedure that looks and feels similar, but without the active treatment, to compare results fairly.
Will I know if I receive the real treatment or the sham control?
No, neither you nor your doctor will know which treatment you receive. This is to ensure the study results are as unbiased as possible.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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