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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Denervation | Experimental | Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary arterial 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Intra-Vascular UltraSound (TIVUS™) System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of all procedural related adverse event as assessed by the CEC | Procedural related Adverse Events | 1 month |
| Amount of treatment related adverse event as assessed by the CEC | All treatment related adverse events | 12 month |
| Number of patient with PAH worsening and all cause death events | PAH related adverse events and all cause death | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical effectiveness | Changes from baseline of mean pulmonary arterial pressure (mPAP) | 6 months |
| Clinical effectiveness | Changes from baseline of pulmonary vascular resistance (PVR) |
| Measure | Description | Time Frame |
|---|---|---|
| Observational Variables | Changes from baseline of mean pulmonary arterial pressure (mPAP) | 12 Months |
| Observational Variables | Changes from baseline of pulmonary vascular resistance (PVR) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health | San Diego | California | 92103 | United States | ||
| University of Michigan |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
|
| 6 months |
| Clinical effectiveness | Changes from baseline of 6 minute walking distance (6MWD) | 6 months |
| Clinical effectiveness | Changes from baseline of quality of life questionaire | 6 months |
| Clinical effectiveness | NT-pro-BNP levels | 1, 6 and 12 months |
| Clinical efffectivness | Change from baseline in Right Ventricular (RV) function as assesed by MRI | 6 months |
| Clinical efffectivness | Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography | 6 months |
| 12 Months |
| Observational Variables | Changes from baseline of 6 minute walking distance (6MWD) | 12 Months |
| Observational Variables | Changes from baseline of quality of life questionaire | 12 Months |
| Observational Variables - Long term surveillance | Clinical change of pulmonary arterial hypertension condition defined by patient survival or cause of mortality | 2, 3, 4 and 5 years |
| Observational Variables - Long term surveillance | Clinical change of pulmonary arterial hypertension condition defined by hospitalization due to pulmonary arterial hypertension | 2, 3, 4 and 5 years |
| Observational Variables - Long term surveillance | Clinical change of pulmonary arterial hypertension condition defined by any intervention or surgical procedures the patient did | 2, 3, 4 and 5 years |
| Observational Variables - Long term surveillance | Clinical change of pulmonary arterial hypertension condition defined by worsening of WHO functional class | 2, 3, 4 and 5 years |
| Observational Variables - Long term surveillance | Clinical change of pulmonary arterial hypertension condition defined by escalation of drug therapy | 2, 3, 4 and 5 years |
| Observational Variables | Echocardiography parameters | 12 month |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Columbia University Medical Center/NewYork Presbyterian Hospital | New York | New York | 10032 | United States |
| UT Southwestren Medical Center | Dallas | Texas | 75390 | United States |