Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
study ends around

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

Eligibility

Locations

  • UC San Diego Health
    San Diego California 92103 United States
  • UT Southwestren Medical Center
    Dallas Texas 75390 United States
  • University of Michigan
    Ann Arbor Michigan 48109 United States
  • Columbia University Medical Center/NewYork Presbyterian Hospital
    New York New York 10032 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
SoniVie Inc.
ID
NCT02835950
Study Type
Interventional
Participants
Expecting 15 study participants
Last Updated