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The objective of this study is to assess the safety and initial effectiveness of the TIVUSâ„¢ 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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary Denervation | Device | Pulmonary Denervation (PDN) using the TIVUSâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 month |
| Change in resting mean right atrial pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Medical Center | San Diego | California | 92037 | United States | ||
| University of California, San Francisco Medical Center |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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Change in resting mean atrial pressure (mRAP) from baseline
| 4 month |
| Changes in 6MWD from baseline | Changes in 6MWD from baseline | 4 month |
| Changes in Echocardiography parameters | Changes in Echocardiography parameters including Right Ventricular function from baseline | 4 month |
| Change in NT-BNP levels | Change in NT-BNP levels from baseline | 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. | 12 month |
| Change in exercise mean right atrial pressure | Change in exercise mean right atrial pressure (mRAP) from baseline | 4 month |
| Change in exercise mean pulmonary artery pressure | Change in exercise mean pulmonary artery pressure (mPAP) from baseline | 4 month |
| Change in exercise pulmonary vascular resistance | Change in exercise pulmonary vascular resistance (PVR) from baseline | 4 month |
| Change in exercise cardiac index | Change in exercise cardiac index (CI) from baseline | 4 month |
| Change in resting mean pulmonary artery pressure | Change in resting mean pulmonary artery pressure (mPAP) from baseline | 4 month |
| Change in resting pulmonary vascular resistance | Change in resting pulmonary vascular resistance (PVR) from baseline | 4 month |
| Change in resting cardiac index | Change in resting cardiac index (CI) from baseline | 4 month |
| San Francisco |
| California |
| 94158 |
| United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | United States |
| D002318 |
| Cardiovascular Diseases |