TROPHY: TReatment Of Pulmonary HYpertension 1 Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pulmonary Denervation 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. |
Device: Therapeutic Intra-Vascular UltraSound (TIVUS™) System
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.
|
Outcome Measures
Primary Outcome Measures
- Safety evaluation of the PDN procedure (Procedural related Adverse Events) [1 month]
Procedural related Adverse Events
- Safety evaluation of the PDN procedure (PAH related adverse events and all cause death) [12 month]
PAH related adverse events and all cause death
Secondary Outcome Measures
- Clinical effectiveness [4 months]
Changes from baseline of mean pulmonary arterial pressure (mPAP)
- Clinical effectiveness [4 months]
Changes from baseline of pulmonary vascular resistance (PVR)
- Clinical effectiveness [4 months]
Changes from baseline of 6 minute walking distance (6MWD)
- Clinical effectiveness [4 months]
Changes from baseline of quality of life questionaire
Other Outcome Measures
- Observational Variables [12 Months]
Changes from baseline of Nt-pro-BNP
- Observational Variables [12 Months]
Changes from baseline of mean pulmonary arterial pressure (mPAP)
- Observational Variables [12 Months]
Changes from baseline of pulmonary vascular resistance (PVR)
- Observational Variables [12 Months]
Changes from baseline of 6 minute walking distance (6MWD)
- Observational Variables [12 Months]
Changes from baseline of quality of life questionaire
- Observational Variables - Long term surveillance [3 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced or familial PAH
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PAH diagnosis confirmed by hemodynamic evaluation performed prior to screening and showing all of the following: Mean pulmonary artery pressure (mPAP) ≥25 mmHg at rest; Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) ≤15 mmHg; Pulmonary vascular resistance (PVR) at rest >3 Wood units; Not meeting the criteria for a positive vasodilator response (fall in mPAP ≥ 10 mmHg to ≤ 40 mmHg).
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Patient with a current diagnosis of WHO functional class III
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Patient should be on two pulmonary arterial hypertension specific medications other than parenteral prostanoids
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Patient is adhering to a stable drug regimen (i.e., with no changes of dose or medication for a minimum of 3 months prior to enrollment)
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Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l
Exclusion Criteria:
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Patient who are treated with parenteral prostanoids
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Pregnant women or women planning a pregnancy within 12 months of study enrolment
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Patient with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry
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Patient with life expectancy of less than a year
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Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor)
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Patient with pulmonary artery anatomy that precludes treatment
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Patient with moderate to severe pulmonary artery stenosis
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Patient with any pulmonary artery aneurysm
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Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Erasme | Bruxelles | Belgium | ||
| 2 | Kaplan Hospital | Rehovot | Israel | ||
| 3 | Hammersmith Hospital, Imperial College Healthcare NHS Trust | London | United Kingdom | ||
| 4 | Royal Hallamshire Hospital, | Sheffield | United Kingdom |
Sponsors and Collaborators
- SoniVie Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLNS01-001