Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
SoniVie Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH, connective tissue disease PAH, Anorexogen induced or Heritable PAH
PAH diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest; Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg; Pulmonary vascular resistance (PVR) at rest \>3 Wood units; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤ 40 mmHg).
Patient with a current diagnosis of WHO functional class III
Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids
Patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l
You may not be if
Patients who are treated with parenteral prostanoids
Pregnant women or women planning a pregnancy within 12 months of study enrolment
Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry
Patient with life expectancy of less than a year
Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
Patient with pulmonary artery anatomy that precludes treatment
Patient with moderate to severe pulmonary artery stenosis
Patient with any pulmonary artery aneurysm
Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
Patient who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices
