Clinical trial NCT02516722: TReatment Of Pulmonary HYpertension 1 Study
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: SoniVie Inc.
Sponsor class: INDUSTRY
First posted: 2015-08-06
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 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.


Eligibility criteria: Inclusion Criteria:

* Patient with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced or familial 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 should be on 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:

* Patient who are treated with parenteral prostanoids
* Pregnant women or women planning a pregnancy within 12 months of study enrolment
* Patient with significant co-morbid conditions 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

Primary outcomes:
measure: Safety evaluation of the PDN procedure (Procedural related Adverse Events)
timeFrame: 1 month
measure: Safety evaluation of the PDN procedure (PAH related adverse events and all cause death)
timeFrame: 12 month
Secondary outcomes:
measure: Clinical effectiveness
timeFrame: 4 months
measure: Clinical effectiveness
timeFrame: 4 months
measure: Clinical effectiveness
timeFrame: 4 months
measure: Clinical effectiveness
timeFrame: 4 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
timeFrame: 12 Months
measure: Observational Variables - Long term surveillance
timeFrame: 3 years
Locations:
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Rehovot
country: Israel
facility: Kaplan Hospital
city: London
country: United Kingdom
facility: Hammersmith Hospital, Imperial College Healthcare NHS Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital,
Study officials:
References: