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.

Study Contact