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.
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:
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.
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: