Pulmonary Arterial Hypertension
Conditions
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 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.
Interventions
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.
Sponsors
SoniVie Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with known pulmonary arterial hypertension (PAH), diagnosed as idiopathic PAH, connective tissue disease PAH, Anorexogen induced or Heritable PAH * 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). * Patient with a current diagnosis of WHO functional class III * Patient taking two pulmonary arterial hypertension specific medications other than parenteral prostanoids * 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) * Patient with eGFR levels of ≥ 30 ml/min/1.73m2or serum creatinine levels of ˂ 150µmol/l
Exclusion criteria
* Patients who are treated with parenteral prostanoids * Pregnant women or women planning a pregnancy within 12 months of study enrolment * Patient with significant co-morbid condition(s) which, at the discretion of the PI, are deemed to prohibit study entry * Patient with life expectancy of less than a year * Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor) * Patient with pulmonary artery anatomy that precludes treatment * Patient with moderate to severe pulmonary artery stenosis * Patient with any pulmonary artery aneurysm * Patient who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months * Patient who has implantable cardiac pacemakers, ICDs, neurostimulators, or drug infusion devices * Patients who are unable to undergo an MRI scan
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of treatment related adverse event as assessed by the CEC | 12 month | All treatment related adverse events |
| Amount of all procedural related adverse event as assessed by the CEC | 1 month | Procedural related Adverse Events |
| Number of patient with PAH worsening and all cause death events | 12 month | PAH related adverse events and all cause death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efffectivness | 6 months | Change from baseline in Right Ventricular (RV) function as assesed by MRI |
| Clinical effectiveness | 6 months | Changes from baseline of mean pulmonary arterial pressure (mPAP) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Observational Variables | 12 Months | Changes from baseline of mean pulmonary arterial pressure (mPAP) |
| Observational Variables - Long term surveillance | 2, 3, 4 and 5 years | Clinical change of pulmonary arterial hypertension condition defined by patient survival or cause of mortality |
Countries
United States
Outcome results
None listed