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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
The TIVUS™ System generates high intensity, non-focused ultrasonic energy that is delivered through the wall of the pulmonary artery to achieve local nerve deactivation. Denervation in the pulmonary arteries (PDN) would be performed during right heart catheterization. The PDN procedure would be attempted in the main, right and left pulmonary arteries, close to the main bifurcation.
UC San Diego Health
San Diego, California, United States
University of Michigan
Ann Arbor, Michigan, United States
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, United States
UT Southwestren Medical Center
Dallas, Texas, United States
Amount of all procedural related adverse event as assessed by the CEC
Procedural related Adverse Events
Time frame: 1 month
Amount of treatment related adverse event as assessed by the CEC
All treatment related adverse events
Time frame: 12 month
Number of patient with PAH worsening and all cause death events
PAH related adverse events and all cause death
Time frame: 12 month
Clinical effectiveness
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Time frame: 6 months
Clinical effectiveness
Changes from baseline of pulmonary vascular resistance (PVR)
Time frame: 6 months
Clinical effectiveness
Changes from baseline of 6 minute walking distance (6MWD)
Time frame: 6 months
Clinical effectiveness
Changes from baseline of quality of life questionaire
Time frame: 6 months
Clinical effectiveness
NT-pro-BNP levels
Time frame: 1, 6 and 12 months
Clinical efffectivness
Change from baseline in Right Ventricular (RV) function as assesed by MRI
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Time frame: 6 months
Clinical efffectivness
Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography
Time frame: 6 months