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The objective of this study is to assess the safety, performance and initial effectiveness of the TIVUSâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary Denervation | Experimental | Pulmonary Denervation (PDN) using the TIVUSâ„¢ 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 (TIVUSâ„¢) System | Device | The TIVUSâ„¢ 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 |
|---|---|---|
| Safety evaluation of the PDN procedure (Procedural related Adverse Events) | Procedural related Adverse Events | 1 month |
| Safety evaluation of the PDN procedure (PAH related adverse events and all cause death) | 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) | 4 months |
| Clinical effectiveness | Changes from baseline of pulmonary vascular resistance (PVR) |
| Measure | Description | Time Frame |
|---|---|---|
| Observational Variables | Changes from baseline of Nt-pro-BNP | 12 Months |
| Observational Variables | Changes from baseline of mean pulmonary arterial pressure (mPAP) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Erasme | Brussels | Belgium | ||||
| Kaplan Hospital |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 5, 2022 | |
| Reset | Oct 28, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2022 | Oct 28, 2022 |
| 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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|
| 4 months |
| Clinical effectiveness | Changes from baseline of 6 minute walking distance (6MWD) | 4 months |
| Clinical effectiveness | Changes from baseline of quality of life questionaire | 4 months |
| 12 Months |
| Observational Variables | Changes from baseline of pulmonary vascular resistance (PVR) | 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 a. Survival or the cause of mortality; b. Hospitalization due to pulmonary arterial hypertension; c. Intervention or surgical procedures; d. Worsening of WHO functional class and/or e. Escalation of drug therapy | 3 years |
| Rehovot |
| Israel |
| Hammersmith Hospital, Imperial College Healthcare NHS Trust | London | United Kingdom |
| Royal Hallamshire Hospital, | Sheffield | United Kingdom |