Ensayos clínicos

Inclusion Criteria:

• 18 years or older.
• Diagnosis of WHO Group 1 PH (Pulmonary Arterial Hypertension, PAH) evidenced by all the following parameters measured at rest:
  • Mean pulmonary artery pressure (mPAP) ≥ 25 mmHg;
  • Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg;
  • Pulmonary vascular resistance (PVR) > 3 Wood units.
• 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.
• Patient with a current assessment of WHO FC III.
• 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).
• 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).
• 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:

• Under 18 years old.
• Diagnosis of WHO PH Groups 2, 3, 4 or 5.
• Patient with recent clinical events of any of the following:
  • Myocardial infarction or stroke within 6 months prior to the index procedure;
  • Sustained tachyarrhythmia (documented heart rate > 110/min) within 2 months prior to the index procedure.
• 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.).
• Patient with any of the following medical history or comorbidities:
  • History of endocarditis;
  • Current renal insufficiency as demonstrated by a serum creatinine > 2.0 mg/dL or end stage renal disease requiring chronic dialysis;
  • Current scleroderma, or other collagen vascular disease treated with immuno-suppressant;
  • Current pulmonary veno-occlusive disease (PVOD);
  • Current pulmonary capillary hemangiomatosis (PCH);
  • History of clinically significant patent foramen ovale or other inter-atrial or inter-ventricular shunt;
  • 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;
  • Current active systemic infection requiring antibiotic therapy;
  • 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.
• Anatomy not suitable for placement of Aria CV device, including:
  • No suitable subcutaneous implantation location for the reservoir;
  • Contraindication to 22 Fr venous access via a subclavian vein;
  • Body habitus that precludes safe placement of any components of the Aria CV device.
• Right heart valve regurgitation:
  • Moderate to severe (Grade 3 or 4) pulmonary valve regurgitation;
  • Severe (Grade 4) tricuspid valve regurgitation.
• Hypersensitivity or contraindication to:
  • Required medications (e.g., contrast agents, warfarin, heparin) which cannot be adequately managed;
  • Materials in device including polyurethane, silicone, nickel, and titanium.
• Patient ineligible for or refuses blood transfusion.
• Pregnant or lactating female or planning a pregnancy during participation in the study.
• Patient with life expectancy of less than two years.
• Currently participating in or planning to participate in other investigational drug or device trials that may interfere with the outcome of this study.