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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 arterial hypertension.

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 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. Up to 45 patients will be consented, and up to 15 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-, 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. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04555161
Study type Interventional
Source Aria CV, Inc
Status Suspended
Phase N/A
Start date March 15, 2021
Completion date June 30, 2025

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