An Early Feasibility Study Assessing Treatment of Pulmonary 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 hypertension and right heart dysfunction.
• 18 years of age or older.
• Mean pulmonary artery pressure (mPAP) \> 25mmHg.
• Right heart dysfunction as evidence by at least one of the following:
∙ Tricuspid Annulus Plan Systolic Excursion (TAPSE) ≤ 16mm
‣ RV Fractional area change \< 35%
‣ RV systolic velocity \< 11.5 cm/s
‣ RV free wall strain \< 18%
‣ Lateral tricuspid annulus peak systolic velocity (S') \< 9cm/s
• Pulmonary compliance (C) \< 3.0 ml/mmHg
• Current assessment of WHO FC III or ambulatory IV
• 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).
• 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).
• The subject has agreed to participate in the study by signing the study specific informed consent form.
• The subject agrees to abide by device related travel restrictions.
⁃ Pulmonary capillary wedge pressure (PCWP) ≤ 15mmHg
⁃ Pulmonary vascular resistance (PVR) \> 3 Woods Units (WU)
⁃ 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