TReatment of Pulmonary Hypertension Group II Study
The objective of this study is to assess the safety and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation in group II PH patients through change in clinical parameters including hemodynamics, exercise tolerance, and quality of life. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 3 centers and will recruit up to 15 patients diagnosed with pulmonary hypertension due to left heart disease that demonstrate combined pre and post capillary involvement with PVR>3 wood units.
- Pulmonary Hypertension (PH) Due to Left Heart Disease
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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.
- Study Type
- Intervention Model
- Single Group Assignment
- Primary Purpose
- None (Open Label)
- NCT ID
- SoniVie Ltd.
Study ContactDalit Shav, PhD