You may qualify for a clinical study.

If you have been diagnosed with pulmonary arterial hypertension (PAH) and your current medications are not providing adequate relief of your symptoms, you may qualify for a clinical study involving a novel investigational medical device for the treatment of PAH, the Aria CV Pulmonary Hypertension System (Aria CV PH System).

Information provided here is to help you assess whether treatment with the Aria CV PH System might be an option for you.

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What is PAH?

A pulmonary arterial hypertension (PAH) diagnosis means that you have high blood pressure in the arteries that go from your heart to your lungs. It is a rare, progressive disorder, different from regular high blood pressure.

Normally, blood flows easily from the right side of the heart through the blood vessels to the lungs. The blood pressure is normally low because the blood vessels from the right heart to the lungs as well as those in the lungs are open and elastic (easily expanded). In people with PAH, the blood vessels become narrow and stiff. This makes it hard for blood to flow to and through your lungs, causing an increase in the pressure in the blood vessels. As a result, your heart has to pump harder to push the blood through. This initially may cause you to become short of breath and feel tired. If left untreated, over time, PAH can overwork your heart and increase the chance of your heart failing.

What are the most common causes of PAH?

A number of things can cause PAH. These include inherited genetic conditions, other diseases, and outside factors. There are also cases where the cause of PAH is not known.

PAH Cause
Description
Idiopathic PAH (iPAH)
Idiopathic means the cause is not known
Familial or heritable PAH (hPAH)
This means the disease runs in a family
Connective tissue disorders (CTD)
PAH associated with CTD
Congenital heart disease (CHD)
PAH associated with CHD with repaired shunts
Other causes
PAH associated with other diseases and conditions

What are current treatment options?

The most common treatment for PAH is vasodilating drugs which work to relax the blood vessels. In the past several years, combination therapy (i.e. simultaneous use of more than one PAH-specific class of drugs) has become more commonly used.

Even with combination therapy, some patients do not respond and continue to decline. For these patients, there are several rarely used invasive strategies such as atrial septostomy (a procedure where a small hole is made in the wall between the left and right atria of the heart) and extracorporeal membrane oxygenation (ECMO, a treatment that uses a pump to circulate blood through an artificial lung back into the bloodstream). Currently, the only curative option for end-stage disease is lung or heart-lung transplantation.

The Aria CV PH System was developed as a catheter-based, minimally invasive interventional device and procedure that may potentially provide an alternative to currently approved therapy.

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What is Aria CV PH System and how does it work?

The Aria CV Pulmonary Hypertension System (Aria CV PH System, Aria Device, or Device) is an investigational device that is currently being studied in the United States and is aimed at treating patients with PAH. The Aria CV PH System includes an implantable gas-filled Balloon that is placed in the body through a small hole in the skin and anchored in the main pulmonary artery. The Balloon collapses (in systole) and expands (in diastole) with the cardiac cycle, potentially restoring compliance to the PA vasculature.

As a result, the cyclic blood pressure changes in pulmonary arteries may be evened out, with the goal of mimicking the function of healthy elastic pulmonary arteries, which may provide the following benefits:

  1. Potentially reduce workload of the right side of the heart,
  2. Impact the amount of blood that flows from the heart to the lungs, and
  3. Potentially lower cyclic pressure changes in pulmonary arteries, which may impact the harmful effects on stiffened pulmonary arteries

What is the ASPIRE PH study?

The ASPIRE PH Study is an early feasibility investigational device study conducted in the United States to evaluate the safety and performance of the Aria CV PH System in patients with PAH. Early feasibility studies enroll only a small number of patients and are designed to gain initial insights into the basic safety and functionality of a new medical device. It means that the device has not been approved for use anywhere in the world, so the device and implant procedure are experimental, and the device’s safety and effectiveness are unproven. It also means that there is limited information and experience treating the condition with the study device. Some risks are unknown and there is no guarantee that the study device will provide benefit.

However, if the study device performs as intended, it could improve the patient’s medical condition. Additionally, data from the study may provide new medical information that helps physicians treat other patients with similar health problems. It may also be used by the manufacturer to improve the device or to design additional clinical studies in support of regulatory approvals of this device.

Note: Prior to deciding to participate in any clinical study, you should learn as much as possible about your disease and treatment options. You should discuss all your options with your physician. You should feel comfortable with a decision to participate or not.

Am I Potentially Eligible?

The Aria CV PH System is indicated for the treatment of adult patients with World Health Organization (WHO) Group I Pulmonary Arterial Hypertension who remain symptomatic despite treatment with optimal medical therapy. Further assessments will be needed before your study physician can determine whether you are indeed eligible to participate in this study. Inclusion criteria include:

  • Diagnosis with Pulmonary Arterial Hypertension (PAH)
  • Symptomatic despite being on multiple PH-specific medications
  • Current assessment of WHO Functional Class III

What to Expect if you decide to participate?

  1. Your study physician will discuss the risks, benefits, and your responsibilities as a study participant. Before you can participate in the study, you will need to sign an Informed Consent form after understanding details regarding the study, device and procedure.
  2. Your physician will perform tests and procedures. You will be required to have tests prior to, during and after your study procedure. These tests include, but are not limited to the following, most of which are standard of care for patients with PAH.
    1. Physical exam and detailed medical history
    2. Imaging, including a CT scan and echocardiograms (ultrasound imaging)
    3. Blood tests
    4. Right heart catheterization
    5. Questionnaires and 6 Minute Walk Distance Test
  3. Complete follow-up visits. You will need to return for follow-up visits regularly through 2 years after your procedure.
    Participation ends after your 2-year visit.

Clinical study information

The ASPIRE PH Study will be enrolling patients with advanced PAH. To learn more about this study and find a study center near you, go to:

Clinicaltrials.gov