Status unknownNCT02516722TROPHYUpdated Mar 16, 2021

TReatment Of Pulmonary HYpertension 1 Study

An interventional study of Therapeutic Intra-Vascular UltraSound (TIVUS™) System in Pulmonary Arterial Hypertension, sponsored by SoniVie Inc.. Status unknown at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-16.

Sponsored by SoniVie Inc. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 15
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Pulmonary Arterial Hypertension

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In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 15 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

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Lead sponsor

SoniVie Inc. is the lead sponsor of 6 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 15 participants (estimated)

Study arms

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

Interventions

DeviceTherapeutic 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.

What researchers measure

Primary outcomes

Safety evaluation of the PDN procedure (Procedural related Adverse Events)
Procedural related Adverse Events
Time frame: 1 month
Safety evaluation of the PDN procedure (PAH related adverse events and all cause death)
PAH related adverse events and all cause death
Time frame: 12 month

Secondary outcomes

Clinical effectiveness
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Time frame: 4 months
Clinical effectiveness
Changes from baseline of pulmonary vascular resistance (PVR)
Time frame: 4 months
Clinical effectiveness
Changes from baseline of 6 minute walking distance (6MWD)
Time frame: 4 months
Clinical effectiveness
Changes from baseline of quality of life questionaire
Time frame: 4 months

Other outcomes

Observational Variables
Changes from baseline of Nt-pro-BNP
Time frame: 12 Months
Observational Variables
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Time frame: 12 Months
Observational Variables
Changes from baseline of pulmonary vascular resistance (PVR)
Time frame: 12 Months
Observational Variables
Changes from baseline of 6 minute walking distance (6MWD)
Time frame: 12 Months
Observational Variables
Changes from baseline of quality of life questionaire
Time frame: 12 Months
Observational Variables - Long term surveillance
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
Time frame: 3 years

Study locations

4 sites

Hôpital Erasme
Bruxelles, Belgium
Kaplan Hospital
Rehovot, Israel
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Hallamshire Hospital,
Sheffield, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02516722
Lead sponsor: SoniVie Inc.
Responsible party: Sponsor
First posted: Aug 6, 2015
Start date: Feb 2016
Primary completion: Oct 2018
Completion: Jun 2021 (estimated)
Last update: Mar 16, 2021

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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