Clinical trial NCT02835950: TReatment Of Pulmonary HYpertension 1-US Study
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: SoniVie Inc.
Sponsor class: INDUSTRY
First posted: 2016-07-18
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Amount of all procedural related adverse event as assessed by the CEC
timeFrame: 1 month
measure: Amount of treatment related adverse event as assessed by the CEC
timeFrame: 12 month
measure: Number of patient with PAH worsening and all cause death events
timeFrame: 12 month
Secondary outcomes:
measure: Clinical effectiveness
timeFrame: 6 months
measure: Clinical effectiveness
timeFrame: 6 months
measure: Clinical effectiveness
timeFrame: 6 months
measure: Clinical effectiveness
timeFrame: 6 months
measure: Clinical effectiveness
timeFrame: 1, 6 and 12 months
measure: Clinical efffectivness
timeFrame: 6 months
measure: Clinical efffectivness
timeFrame: 6 months
Other outcomes:
measure: Observational Variables
timeFrame: 12 Months
measure: Observational Variables
timeFrame: 12 Months
measure: Observational Variables
timeFrame: 12 Months
measure: Observational Variables
timeFrame: 12 Months
measure: Observational Variables - Long term surveillance
timeFrame: 2, 3, 4 and 5 years
measure: Observational Variables - Long term surveillance
timeFrame: 2, 3, 4 and 5 years
measure: Observational Variables - Long term surveillance
timeFrame: 2, 3, 4 and 5 years
measure: Observational Variables - Long term surveillance
timeFrame: 2, 3, 4 and 5 years
measure: Observational Variables - Long term surveillance
timeFrame: 2, 3, 4 and 5 years
measure: Observational Variables
timeFrame: 12 month
Locations:
city: San Diego
country: United States
facility: UC San Diego Health
state: California
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center/NewYork Presbyterian Hospital
state: New York
city: Dallas
country: United States
facility: UT Southwestren Medical Center
state: Texas
Study officials:
References: