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

Summary

Participation Requirements

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 Ar...

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.

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