RecruitingNAINTERVENTIONAL

Reducing Right Ventricular Failure in Pulmonary Arterial Hypertension (RELIEVE-PAH)

The RELIEVE-PAH study is looking at a new device called a V-Wave Interatrial Shunt for patients living with severe pulmonary arterial hypertension (PAH). PAH is a serious condition that affects the arteries in the lungs, making it harder for the heart to pump blood. This study wants to find out if this new device is safe to use in humans, if it works correctly, and if it shows any early signs of helping patients feel better by reducing strain on the right side of their heart. It's an important first step to understand if this device could become a new treatment option in the future. The study will involve a small number of patients who will be carefully monitored over several years.

At a glance

Status

Recruiting

Phase

Sponsor

V-Wave Ltd

Enrolment target

Start

14 Feb 2020

Estimated completion

31 Dec 2031

Pulmonary Arterial Hypertension

What is this study about?

This research study, called RELIEVE-PAH, is exploring a new way to help people with a condition called pulmonary arterial hypertension, or PAH. PAH makes it difficult for blood to flow through the arteries in the lungs, which then puts a lot of strain on the right side of the heart. Over time, this can lead to heart failure.

The study involves a new device called a V-Wave Interatrial Shunt. This device is designed to create a small connection between the upper chambers of the heart. The idea behind this is to relieve some of the pressure on the right side of the heart, which might help reduce symptoms and improve how patients feel. This is one of the first times this device will be used in people, so the main goals are to make sure it's safe, that it works correctly inside the body, and to see if there are any early signs that it could be an effective treatment.

Understanding how this device performs is crucial. If it shows promise, it could eventually offer a new treatment option for patients who haven't found enough relief from existing medicines. This study is an important step in gathering that initial information.

Key takeaways

This study is for adults with severe pulmonary arterial hypertension (PAH).
It's testing a new device called a V-Wave Interatrial Shunt.
The main goals are to check the device's safety and see if it helps.
Participation involves having the device implanted and regular follow-up for up to 5 years.
You will continue your usual PAH medications during the study.
It's an early-stage study, so potential benefits and risks are being carefully investigated.

Who may be eligible?

This study is looking for adults aged 18 and over who have been diagnosed with a specific type of pulmonary arterial hypertension (PAH). You would need to be experiencing moderate to severe symptoms despite already taking the highest possible and well-tolerated medications for your PAH for at least three months, with your doses stable for at least one month.

There are also some reasons why you might not be able to join. For example, if your oxygen levels are very low without extra oxygen, or if you have very high pressure in a certain part of your heart. People with severe lung conditions that aren't PAH, or other organ problems (besides issues from heart failure), would also not be able to participate. If your heart's main pumping chamber (the left ventricle) isn't pumping strongly enough, or if a scan shows that the device can't be placed properly due to your heart's structure, you wouldn't be eligible.

Finally, if you have certain severe heart rhythm problems, or are unstable with your breathing or blood flow when the final checks are done, you wouldn't be able to join the study. The medical team will carefully check all these points to see if the study is right for you.

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?
Do you have a specific type of Group 1 Pulmonary Arterial Hypertension (PAH)?
Are your PAH symptoms moderate to severe (WHO Functional Class III or IV)?
Have you been on your maximum, stable PAH medications for at least three months?
Are your resting oxygen levels usually above 90% without extra oxygen?
Have you been told you don't have very severe other lung conditions or severe other organ problems?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part in this study, a total of up to 20 patients will have the V-Wave Interatrial Shunt device placed in their heart. This procedure will be followed by regular check-ups. For the first year after the device is implanted, you will have several appointments to monitor your health and how the device is working. After this initial year, you will have annual check-ups for a total of five years. These appointments will involve various assessments to ensure your safety and track any potential benefits from the device. The study will not involve new medications beyond what you are already taking for your PAH, but your current medications will be closely monitored.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as possibly improving your heart function and reducing symptoms if the device works as hoped. However, like any medical procedure involving a new device, there are potential risks, including the risks associated with the implantation procedure itself, and the possibility that the device may not work or could cause side effects. Your doctor will discuss all known and potential risks with you in detail. Remember, choosing to participate is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

Keck Medical Center of USC
Verified postcode
Los Angeles, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
The Ohio State University Wexner Medical Center - Davis Heart & Lung Research Institute
Verified postcode
Columbus, United States· Withdrawn
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Verified postcode
Québec, Canada· Withdrawn
Instituto Nacional de Cardiologia
Verified postcode
Mexico City, Mexico· Active not recruiting

Common questions

What is pulmonary arterial hypertension (PAH)?

PAH is a serious condition where the blood vessels in your lungs become narrowed, making it hard for your heart to pump blood through them, which puts a strain on your heart.

What is the V-Wave Interatrial Shunt?

It's a new device being tested that aims to create a small opening between the upper chambers of your heart to help relieve pressure on the right side of your heart if you have PAH.

Is this device approved for everyone with PAH?

No, this is a research study to see if the device is safe and effective. It is not currently approved for general use, and is only being tested on a small group of patients.

How long would I be in the study?

If you participate, you would be followed for one year with more frequent visits, and then annually for a total of five years after the device is implanted.

Do I have to stop my current PAH medications?

No, you will continue to take your current PAH medications at a stable dose. The study aims to see if the device can help alongside your existing treatment.

How to find out more

William T. Abraham, M.D.

bill@vwavemedical.com (818)629-2164 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.