Pulmonary Arterial HypertensionTROPHY 1-USNCT02835950
TReatment Of Pulmonary HYpertension 1-US Study
A study testing Therapeutic Intra-Vascular UltraSound (TIVUS™) System in people with Pulmonary Arterial Hypertension, run by SoniVie Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Therapeutic Intra-Vascular UltraSound (TIVUS™) System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2017to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Michigan
Ann Arbor, Michigan, 48109
UT Southwestren Medical Center
Dallas, Texas, 75390
Columbia University Medical Center/NewYork Presbyterian Hospital
New York, New York, 10032
UC San Diego Health
San Diego, California, 92103
About this study
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
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.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Therapeutic Intra-Vascular UltraSound (TIVUS™) System
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Intra-Vascular UltraSound (TIVUS™) SystemDevice
Also called TIVUS™
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.
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Denervation | Experimental | 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. Receives: Device: Therapeutic Intra-Vascular UltraSound (TIVUS™) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of all procedural related adverse event as assessed by the CEC
Procedural related Adverse Events
Measured: 1 month
Amount of treatment related adverse event as assessed by the CEC
All treatment related adverse events
Measured: 12 month
Number of patient with PAH worsening and all cause death events
PAH related adverse events and all cause death
Measured: 12 month
Secondary outcomes (7)
Clinical effectiveness
Changes from baseline of mean pulmonary arterial pressure (mPAP)
Measured: 6 months
Clinical effectiveness
Changes from baseline of pulmonary vascular resistance (PVR)
Measured: 6 months
Clinical effectiveness
Changes from baseline of 6 minute walking distance (6MWD)
Measured: 6 months
Clinical effectiveness
Changes from baseline of quality of life questionaire
Measured: 6 months
Clinical effectiveness
NT-pro-BNP levels
Measured: 1, 6 and 12 months
Clinical efffectivness
Change from baseline in Right Ventricular (RV) function as assesed by MRI
Measured: 6 months
Clinical efffectivness
Change from baseline in Right Ventricular (RV) function as assesed by Echocardiography
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study start1 Mar 2017
- Primary completion20 Apr 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SoniVie Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835950
- Sponsor's protocol ID
- CLNS01-001 USA
- Acronym
- TROPHY 1-US
- Status last verified
- Aug 2023
- First submitted
- 10 Jul 2016
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation (PDN) in Patients With Pulmonary Hypertension - US
- ClinicalTrials.gov ID
- NCT02835950
- Acronym / sponsor ID
- TROPHY 1-US / CLNS01-001 USA
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- SoniVie Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 20 Apr 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 18 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Denervation | Experimental | Device: Therapeutic Intra-Vascular UltraSound (TIVUS™) SystemPulmonary 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Intra-Vascular UltraSound (TIVUS™) SystemAlso: TIVUS™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. | Device | Pulmonary Denervation |
Primary outcome
Amount of all procedural related adverse event as assessed by the CEC
Time frame: 1 month
Procedural related Adverse Events
Amount of treatment related adverse event as assessed by the CEC
Time frame: 12 month
All treatment related adverse events
Number of patient with PAH worsening and all cause death events
Time frame: 12 month
PAH related adverse events and all cause death
7 secondary outcomes
Clinical effectiveness
Time frame: 6 months
Clinical effectiveness
Time frame: 6 months
Clinical effectiveness
Time frame: 6 months
Clinical effectiveness
Time frame: 6 months
Clinical effectiveness
Time frame: 1, 6 and 12 months
Clinical efffectivness
Time frame: 6 months
Clinical efffectivness
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Intra-Vascular UltraSound (TIVUS™) System in people with Pulmonary Arterial Hypertension, run by SoniVie Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of all procedural related adverse event as assessed by the CEC (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.