RecruitingNot ApplicableNCT04555161

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

An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System


Sponsor

Aria CV, Inc

Enrollment

30 participants

Start Date

Mar 15, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This prospective study is a multi-center early feasibility study assessing the safety and performance of the Aria CV Pulmonary Hypertension System in patients with pulmonary hypertension and right heart dysfunction.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new implantable device called the Aria CV system, designed to reduce pressure in the lungs for patients with pulmonary arterial hypertension (PAH) — a condition where the blood pressure in the arteries leading to the lungs is dangerously high. **You may be eligible if...** - You are 18 or older with high pressure in your lung arteries (mean pulmonary artery pressure above 25 mmHg) - Your right side of the heart is not functioning well, as shown by specific tests - Your symptoms are severe (WHO functional class III or IV) - You are already on stable medication for pulmonary hypertension - Your lung artery anatomy is suitable for the device **You may NOT be eligible if...** - Your lung or heart anatomy is not appropriate for the device - You are not approved by the study's eligibility review committee - You are unwilling to follow device-related travel restrictions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAria CV Pulmonary Hypertension System

The Aria CV PH System is indicated for the treatment of adult patients diagnosed with Pulmonary Hypertension in World Health Organization (WHO) Groups I, II, and III who remain symptomatic despite treatment with optimal medical therapy.


Locations(12)

University of California - San Diego

La Jolla, California, United States

University of California-Los Angeles

Los Angeles, California, United States

St. Vincent Health

Indianapolis, Indiana, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Cornell University

New York, New York, United States

University of Rochester

New York, New York, United States

The Christ Hospital

Cincinnati, Ohio, United States

Ohio Health

Columbus, Ohio, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Aurora St Luke's Medical Center

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04555161


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