TReatment of Pulmonary Hypertension Group II Study
Purpose
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.
Condition
- Pulmonary Hypertension (PH) Due to Left Heart Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
Exclusion Criteria
- 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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
More Details
- Status
- Active, not recruiting
- Sponsor
- SoniVie Inc.