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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    15
  • sponsor
    Aria CV, Inc
Updated on 26 July 2021
pulmonary arterial hypertension

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 arterial hypertension.

Description

This clinical investigation is a prospective, non-randomized, single- arm, multi-center early feasibility study of the Aria CV Pulmonary Hypertension (PH) System implanted in patients with pulmonary arterial hypertension (PAH). The purpose of this study is to validate that the clinical use of the Aria CV PH System is safe for the patient, and to evaluate its performance in treating patients with PAH.

The study will be conducted in a maximum of 10 centers in the United States with a planned maximum enrollment of 45 patients to ensure up to 15 "Device Deployed" subjects. Patients will be evaluated at each of the following time intervals: preoperative, implant, 7-day (or discharge if earlier) and 1-, 3-, 6-, 12- and 24-month post index procedure. The Aria CV PH System will be assessed at each follow-up visit, as well as at 2- and 9- month and quarterly between 12 and 24 months. The duration of the study is anticipated to be 2.5 years.

Details
Condition Pulmonary Hypertension, Pulmonary Arterial Hypertension
Treatment Aria CV Pulmonary Hypertension System
Clinical Study IdentifierNCT04555161
SponsorAria CV, Inc
Last Modified on26 July 2021

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