An Early Feasibility Study Assessing Treatment of Pulmonary Hypertension Using the Aria CV Pulmonary Hypertension System
Aria CV, Inc
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.
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 i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Common Inclusion Criteria: 1. 18 years of age or older. 2. Mean pulmonary artery pressure (mPAP) \> 25mmHg. 3. Right heart dysfunction as evidence by at least one of the following: 1. Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm 2. RV Fractional area change \< 35% 3. RV systolic velocity \< 11.5 cm/s 4. RV free wall strain \< 18% 5. Lateral tricuspid annulus peak systolic velocity (S') \< 9cm/s 4. Pulmonary compliance (C) \< 3.0 ml/mmHg 5. Current assessment of WHO FC III or ambulatory IV 6. Main pulmonary artery (MPA) diameter and anatomy suitable for placement of…
Interventions
- DeviceAria CV Pulmonary Hypertension System
The Aria CV PH System is indicated for the treatment of adult patients diagnosed with Pulmonary Hypertension in World Health Organization (WHO) Groups I, II, and III who remain symptomatic despite treatment with optimal medical therapy.
Locations (12)
- University of California - San DiegoLa Jolla, California
- University of California-Los AngelesLos Angeles, California
- St. Vincent HealthIndianapolis, Indiana
- Brigham and Women's HospitalBoston, Massachusetts
- University of MinnesotaMinneapolis, Minnesota
- Mayo ClinicRochester, Minnesota