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Clinical Trial 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.


Clinical Trial 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 hypertension (PH). 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 PH and right heart dysfunction. The study will be conducted in a maximum of 20 centers in the United States and up to 30 patients will receive implants. Patients will be evaluated at each of the following time intervals: pre-operative, implant procedure, 7-day (or discharge if earlier), and 1-, 2-, 3-, 4-, 6-, 9-, 12-, 15-, 18-, 21-, and 24-months post index procedure. The Aria CV PH System will be assessed at each follow-up visit. The duration of the study is anticipated to last about 2 years for each patient. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04555161
Study type Interventional
Source Aria CV, Inc
Contact Caytie Longhenry
Phone 651-200-4891
Email clonghenry@ariacv.com
Status Recruiting
Phase N/A
Start date March 15, 2021
Completion date October 2026

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