TReatment Of Pulmonary HYpertension 1 Study

Not Applicable

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT02516722
• Lead Sponsor: SoniVie Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-29
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-06
• Study Start: 2016-02
• Primary Completion: 2018-10
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-16
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Clinical effectiveness	4 months	Changes from baseline of quality of life questionaire

Trial Locations

Locations (4)

Hôpital Erasme; 🇧🇪 Bruxelles, Belgium

Kaplan Hospital; 🇮🇱 Rehovot, Israel

Hammersmith Hospital, Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Royal Hallamshire Hospital,; 🇬🇧 Sheffield, United Kingdom