Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System

{ "Aria CV Pulmonary Hypertension System for Pulmonary Hypertension", "This study is testing a device called the Aria CV Pulmonary Hypertension System for adults with pulmonary hypertension (high blood pressure in the lungs) and right heart dysfunction (when the right side of your heart isn't pumping well). The device is for people who are still having symptoms even after trying other treatments. The main goal of this study is to see if the Aria CV Pulmonary Hypertension System is safe for patients. To join, you must be at least 18 years old and have specific measurements of your lung pressure and heart function. The study plans to enroll up to 30 patients, but the current status of enrollment is unclear.", "design": "This is an early study that will test the device in up to 30 patients at multiple centers. It is a single-arm study, meaning everyone receives the same treatment.", "commitments": "If you participate, you will have the device implanted and attend follow-up visits for about two years. These visits occur at various times, including shortly after the procedure and then regularly for up to 24 months.", "compensation": "Not stated in the trial record.", "follow_up": "Participants will be followed for up to 24 months after the device is implanted to assess its safety and performance.", }

Study design
Not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04555161

Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System

Recruiting
NAAges 18+InterventionalTreatment
Aria CV, Inc
~30 participants
Updated 2025-09-29 on ClinicalTrials.gov
What's tested:Aria CV Pulmonary Hypertension System

At a glance

Recruiting sites
9 of 12 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).
Measured over 30 days post-implant
Pulmonary Arterial Hypertension
Pulmonary Hypertension
Right Heart Dysfunction
12 sites across 8 states
California2
Minnesota2
New York2
Ohio2
Indiana1
Massachusetts1
South Carolina1
Wisconsin1
  • Ashwin Ravichandran, M.D. · PRINCIPAL_INVESTIGATOR · Ascension Health
  • Jim White, M.D., Ph.D. · PRINCIPAL_INVESTIGATOR · University of Rochester

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  • Primary Safety Endpoint is the incidence of investigational device- or procedure-related serious adverse events (SAEs).30 days post-implant

    The primary safety endpoint is the incidence of investigational device- or procedure-related serious adverse events through 30 days post-index procedure.