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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.
UC San Diego Medical Center
San Diego, California, United States
University of California, San Francisco Medical Center
San Francisco, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Procedural related Adverse Events (complications) at up to 30 days post procedure
Procedural related Adverse Events (complications) at up to 30 days post procedure including pulmonary artery perforation/dissection, acute thrombus formation in the pulmonary artery, pulmonary artery aneurysm, vascular stenosis, hemoptysis, all cause PH related as well as procedural related death.
Time frame: 30 days
Changes in cardiopulmonary exercise test
Changes in cardiopulmonary exercise test (CPET) results (Peak VO2, VE/VCO2 slope, VO2 at anaerobic threshold, peak workload) from baseline
Time frame: 4 month
Change in resting mean right atrial pressure
Change in resting mean atrial pressure (mRAP) from baseline
Time frame: 4 month
Changes in 6MWD from baseline
Changes in 6MWD from baseline
Time frame: 4 month
Changes in Echocardiography parameters
Changes in Echocardiography parameters including Right Ventricular function from baseline
Time frame: 4 month
Change in NT-BNP levels
Change in NT-BNP levels from baseline
Time frame: 4 month
Procedure related and PH worsening adverse events
Procedure related and PH worsening adverse events and all cause death up to 12 months will be recorded, and serious adverse events will be reported in accordance with regulatory requirements.
Time frame: 12 month
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Change in exercise mean right atrial pressure
Change in exercise mean right atrial pressure (mRAP) from baseline
Time frame: 4 month
Change in exercise mean pulmonary artery pressure
Change in exercise mean pulmonary artery pressure (mPAP) from baseline
Time frame: 4 month
Change in exercise pulmonary vascular resistance
Change in exercise pulmonary vascular resistance (PVR) from baseline
Time frame: 4 month
Change in exercise cardiac index
Change in exercise cardiac index (CI) from baseline
Time frame: 4 month
Change in resting mean pulmonary artery pressure
Change in resting mean pulmonary artery pressure (mPAP) from baseline
Time frame: 4 month
Change in resting pulmonary vascular resistance
Change in resting pulmonary vascular resistance (PVR) from baseline
Time frame: 4 month
Change in resting cardiac index
Change in resting cardiac index (CI) from baseline
Time frame: 4 month