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
Written informed consent to participate in the study obtained from the patient, according to local regulations, prior to initiation of any study mandated procedure.
Male or female, ≥ 18 years of age at the time of screening
Patient with known pulmonary hypertension (PH) due to left heart disease (WHO Group II) diagnosed as either HFpEF or HFrEF at chronic state receiving stable guideline directed medical therapy.
Combined post-capillary and precapillary pulmonary hypertension diagnosis confirmed by hemodynamic evaluation performed prior to screening or during baseline (Eligibility II visit) procedure
Patient with a current diagnosis of NYHA functional class II/III
Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150μmol/l
You may not be if
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 experiencing a current episode of acute decompensated heart failure
Patient who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrolment. Patient who has implantable Cardiomems device, neurostimulators or drug infusion devices, regardless of implant date.
