Treatment of Pulmonary Arterial Hypertension Using the Aria CV Pulmonary Hypertension System
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 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.
Inclusion Criteria:

 1. 18 years or older.

 2. Diagnosis of WHO Group 1 PH (Pulmonary Arterial Hypertension, PAH) evidenced by all
 the following parameters measured at rest:

 1. Mean pulmonary artery pressure (mPAP) ≥25 mmHg;

 2. Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic
 pressure (LVEDP) ≤15 mmHg;

 3. Pulmonary vascular resistance (PVR) >3 Wood units.

 3. Patient remains symptomatic despite being on a stable drug regimen of at least two PH
 specific medications for at least 90 days prior to planned index procedure.

 4. Patient with a current assessment of WHO Functional Class (FC) III.

 5. Main pulmonary artery (MPA) diameter and anatomy suitable for placement of the device
 as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed
 tomography (MSCT).

 6. Patient is deemed appropriate for Aria CV device by the Patient Care Team at the
 investigation site and approved by the Central Screening Committee (CSC).

 7. Patient understands the study requirements, is willing and able to provide appropriate
 informed consent and is committed and able to attend all required follow-up visits and
 undergo all required tests at the clinic.

 Exclusion Criteria:

 1. Diagnosis of WHO PH Groups 2, 3, 4 or 5.

 2. Patient with recent clinical events of any of the following:

 1. Myocardial infarction or stroke within 6 months prior to the index procedure;

 2. Sustained tachyarrhythmia (documented heart rate >110/min) within 2 months prior
 to the index procedure.

 3. Any pre-existing or requirement of emergent surgery/ intervention, or implantation of
 prosthetic cardiac device that may interfere with Aria CV device placement or function
 (e.g. pulmonary or tricuspid valve repair or replacement, pacemaker, defibrillator,
 inferior vena cava filters, neurostimulators, drug infusion devices, etc.).

 4. Patient with any of the following medical history or comorbidities:

 1. History of endocarditis;

 2. Current renal insufficiency as demonstrated by a serum creatinine > 2.0 mg/dL or
 end stage renal disease requiring chronic dialysis;

 3. Current scleroderma, or other collagen vascular disease treated with
 immuno-suppressant;

 4. Current pulmonary veno-occlusive disease (PVOD);

 5. Current pulmonary capillary hemangiomatosis (PCH);

 6. History of clinically significant patent foramen ovale or other inter-atrial or
 inter-ventricular shunt;

 7. History of gastric antral vascular ectasia (GAVE), gastrointestinal or
 intracranial bleeding which, in the opinion of the investigator, will predispose
 subject to major bleeding events following Aria CV device placement and warfarin
 anticoagulation regimen;

 8. Current active systemic infection requiring antibiotic therapy;

 9. Blood dyscrasias that may, in the opinion of investigator(s), expose patient to
 unacceptable procedural risks such as severe or worsening leukopenia, anemia,
 thrombocytopenia, untreated iron deficiency or history of bleeding diathesis or
 coagulopathy.

 5. Anatomy not suitable for placement of Aria CV device, including

 1. No suitable subcutaneous implantation location for the reservoir;

 2. Contraindication to 22 Fr venous access via a subclavian vein;

 3. Body habitus that precludes safe placement of any components of the Aria CV
 device.

 6. Right heart valve regurgitation:

 1. Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;

 2. Severe (Grade 4) tricuspid valve regurgitation.

 7. Hypersensitivity or contraindication to

 1. Required medications (e.g. contrast agents, warfarin, heparin) which cannot be
 adequately managed;

 2. Materials in device including polyurethane, silicone, nickel, and titanium.

 8. Patient ineligible for or refuses blood transfusion.

 9. Pregnant or lactating female or planning a pregnancy during participation in the
 study.

 10. Patient with life expectancy of less than two years.

 11. Currently participating in or planning to participate in other investigational drug or
 device trials that may interfere with the outcome of this study