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

Eligibility 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 the device as defined in the Instructions For Use (IFU) and as assessed by multi-slice computed tomography (MSCT).
• 7. Subject is deemed appropriate for Aria CV device by the Subject Care Team at the investigation site and approved by the Eligibility Review Committee (ERC).
• 8. The subject has agreed to participate in the study by signing the study specific informed consent form.
• 9. The subject agrees to abide by device related travel restrictions.
• 10. Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg
• 11. Pulmonary vascular resistance (PVR) \> 3 Woods Units (WU)
• 12. The subject remains symptomatic despite being on a stable drug regimen of PH specific medication(s) appropriate for their PH classification for at least 90 days prior to planned index procedure.
• 10. Previous diagnosis of heart failure with preserved ejection fraction (HFpEF) (ejection fraction ≥ 50%) 11. PCWP \> 15 mmHg 12. PVR \> 3 WU
• 10. Previous diagnosis of lung disease, including but not limited to chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD) including idiopathic pulmonary fibrosis (IPF) or combined emphysema with fibrosis.
• 11. PCWP ≤ 15mmHg 12. PVR \>4 WU
• 1. Diagnosis of WHO Groups 4 or 5 PH.
• 2. Recent clinical event(s) 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. Uncontrolled, chronic atrial fibrillation.
• 3. Pre-existing or requirement of emergent surgery/ intervention, or implantation of prosthetic cardiac device that, in the opinion of the investigator, may interfere with Aria CV PH System placement or function.
• 4. Any of the following medical history or comorbidities:
• 5. Anatomy is not suitable for placement of Aria CV device.
• 6. Right heart valve regurgitation as follows:
• 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. Ineligible for or refuses blood transfusion.
• 9. Pregnant, nursing or is planning to become pregnant in the next two years.
• 10. Life expectancy of less than two years.
• 11. Currently participating in or planning to participate in other investigational study that may interfere with the outcome of this study.
• 12. For subject on supplemental oxygen therapy - Subject adheres to the treatment regimen that in the opinion of the physician does not increase subject's safety.
• 13. Previous diagnosis of cardiac amyloidosis.
• 1. Previous diagnosis of idiopathic hypertrophic subaortic stenosis (IHSS, also known as hypertrophic obstructive cardiomyopathy - HOCM).
• 2. Untreated severe aortic or mitral stenosis
• 3. Diagnosis of heart failure with reduced ejection fraction (HFrEF)
• 4. Previous diagnosis of nonobstructive hypertrophic cardiomyopathy.