Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Hyong (Nick) Kim

Description

Summary

The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUS™ System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation. This is a prospective, multi-center, non-randomized, open-label clinical trail. The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH, functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications.

Official Title

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US

Keywords

Pulmonary Arterial Hypertension Hypertension Hypertension, Pulmonary Familial Primary Pulmonary Hypertension Therapeutic Intra-Vascular UltraSound (TIVUS™) System Pulmonary Denervation

Eligibility

You can join if…

Open to people ages 18 years and up

  • Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH,connective tissue disease PAH, Anorexogen induced or Heritable PAH
  • PAH diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest;Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure(LVEDP) ≤15 mmHg; Pulmonary vascular resistance (PVR) at rest >3 Wood units; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤40 mmHg).
  • Patient with a current diagnosis of WHO functional class III
  • Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids
  • Patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
  • Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂150µmol/l

You CAN'T join if...

  • Patients who are treated with parenteral prostanoids
  • 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 who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices
  • Patients who are unable to undergo an MRI scan

Locations

  • UC San Diego Health accepting new patients
    San Diego California 92103 United States
  • UT Southwestren Medical Center accepting new patients
    Dallas Texas 75390 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SoniVie Ltd.
ID
NCT02835950
Lead Scientist
Hyong (Nick) Kim
Study Type
Interventional
Last Updated
April 15, 2018