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 5 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.
Hôpital Erasme
Brussels, Belgium
Kaplan Hospital
Rehovot, Israel
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Hallamshire Hospital,
Sheffield, United Kingdom
Safety evaluation of the PDN procedure (Procedural related Adverse Events)
Procedural related Adverse Events
Time frame: 1 month
Safety evaluation of the PDN procedure (PAH related adverse events and all cause death)
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: 4 months
Clinical effectiveness
Changes from baseline of pulmonary vascular resistance (PVR)
Time frame: 4 months
Clinical effectiveness
Changes from baseline of 6 minute walking distance (6MWD)
Time frame: 4 months
Clinical effectiveness
Changes from baseline of quality of life questionaire
Time frame: 4 months
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