TReatment of Pulmonary Hypertension Group II Study
Running, not enrolling · Not applicable
Conditions studied: Pulmonary Hypertension (PH) Due to Left Heart Disease
In brief
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.
Key facts
- Study ID
- NCT03611270
- Run by
- SoniVie Inc.
- People needed
- 15
- Starts
- 2018-11-30
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2023-08-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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.
Where it is running
- UC San Diego Medical Center — San Diego, California, United States
- University of California, San Francisco Medical Center — San Francisco, California, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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