Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Teresa De Marco

Description

Summary

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.

Official Title

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Hypertension Due to Left Heart Disease

Keywords

Pulmonary Hypertension (PH) Due to Left Heart Disease Hypertension Heart Diseases Hypertension, Pulmonary Pulmonary Denervation

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Locations

  • University of California, San Francisco Medical Center not yet accepting patients
    San Francisco California 94158 United States
  • UC San Diego Medical Center not yet accepting patients
    San Diego California 92037 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
SoniVie Ltd.
ID
NCT03611270
Lead Scientist
Teresa De Marco
Study Type
Interventional
Last Updated