Pulmonary Hypertension Clinical Trial
Official title:
An Early Feasibility Study Assessing Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
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.
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. ;
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