Pulmonary Arterial HypertensionNCT04570228
TROPHY PAH Pivotal Study - TReatment of Pulmonary HYpertension for PAH Pivotal Study
A study testing Pulmonary artery denervation in people with Pulmonary Arterial Hypertension, run by SoniVie Inc..
Trial summary
Theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6M, to assess the safety and effectiveness of pulmonary artery denervation with the TIVUS™ System in subjects with PAH. 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?
- Pulmonary artery denervation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 1 Dec 2025
- 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
- Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.
- Male or female ≥ 18 years of age at the time of screening
- Subject with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced, familial PAH or corrected congenital heart defects more than 1 year prior to enrollment, confirmed by right heart catheterization 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 (240 dyne*s/cm^5)
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- Subject is on maximally tolerated medical therapy for PAH, as determined by his PAH physician
- Subject 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)
- Subject is able to tolerate IV contrast used for the angiograms during treatment
- Subject is WHO functional class II or III
Who cannot join
- Subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months
- Subjects with portal-pulmonary hypertension, Group 2, 3 and 4 PH
- Pregnant women or women planning a pregnancy within 12 months of study enrolment
- Subject with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry
- Subject 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)
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- Subject with pulmonary artery anatomy that precludes treatment with the TIVUS System
- Subject who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months
- Subject experiencing a current episode of acute decompensated heart failure
- Subject who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrollment.
- Subject who has implantable Cardiomems device, or other implanted device that might be contraindicated for therapeutic ultrasound energy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
Theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6M, to assess the safety and effectiveness of pulmonary artery denervation with the TIVUS™ System in subjects with PAH. The study will assess improved and/or maintained exercise tolerance in patients with PAH through the analysis of exercise tolerance, hemodynamic changes, clinical worsening and the quality of life who got treated by the TIVUS system.
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Pulmonary artery denervation, Sham procedure
- 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.
Pulmonary artery denervationDevice
The TIVUS system will be used for pulmonary artery denervation using non focused ultrasound
Sham procedureDevice
A sham procedure would be performed using the TIVUS system without delivering the non focused ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Active comparator | Pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization and pulmonary artery angiography. Receives: Device: Pulmonary artery denervation |
| Sham control group | Sham comparator | A sham treatment of pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization pulmonary artery angiography. The sham procedure will be identical to the denervation procedure, with the only exception that the procedure will use a sham setting on the control console. Receives: Device: Sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walking distance (6MWD)
Statistical difference in 6MWD between the treated group and the sham control group
Measured: 6 months
The rate of procedure and treatment related SAEs reported
Measured: 12 months
Secondary outcomes (11)
Statistical difference between the treated group and the sham control group in exercise tolerance as measured using the change in activity parameters using the Actigraph Centrepoint watch
Measured: 6 months
Difference between time to clinical worsening event between the treated group and the sham control group
Measured: 6 months
Difference between the number of clinical worsening events between the treated group and the sham control group
The definition of clinical worsening events includes: all cause death, hospitalization for worsening PAH, lung/heart transplant, arterial septostomy, initiation of parenteral prostanoid therapy, change in dose and/or number of PAH specific medication. Each event will be counted as a single event and per each patient the total number of events will be recorded
Measured: 6 months
Difference between the treated group and the sham control group in resting mean right atrial pressure (mRAP)
Measured: 6 months
Difference between the treated group and the sham control group in resting mean pulmonary artery pressure (mPAP)
Measured: 6 months
Difference between the treated group and the sham control group in resting pulmonary vascular resistance (PVR)
Measured: 6 months
Difference between the treated group and the sham control group in resting cardiac index (CI)
Measured: 6 months
Difference between the treated group and the sham control group in Quality of Life (QOL) score using the SF36 questionnaire
The SF36 is a 0-100 score, the lower the score is the lower the quality of life is, so that zero is equivalent to maximum disability and a score of 100 is equivalent to no disability at all
Measured: 6 months
Difference between the treated group and the sham control group of NT-pro-BNP levels
Measured: 6 months
Difference between the treated group and the sham control group in patients' clinical pulmonary arterial hypertension condition defined by worsening of World Health Organization (WHO) functional class
PAH patient's WHO functional class is a scale of 1 to 4 based on the symptoms patient experience when doing everyday activities, were Functional Class 1 and 2 are associated with limited effect on patient activity and lower risk status, and Functional Class 3 and 4 are associated with limited activity and higher risk status
Measured: 6 months
Percent of patients who improve or maintain their exercise tolerance (as measured by 6MWD and actigraphy)
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 posted30 Sep 2020
- Study start1 Jan 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Dec 2025 (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
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects will be randomized 2:1 with a sham controlled arm, with subjects and all follow up staff blinded to the subject treatment. Subjects will be unblinded at 6M, and sham control group will be offered treatment at this time if they meet the inclusion/ exclusion criteria. The primary effectiveness endpoint is measured at 6 months. The safety endpoint for blinded patients is at 6 months, and for treated patients again at 12 months.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 205 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
- NCT04570228
- Sponsor's protocol ID
- CLNS03-001 - TROPHY 3 Protocol
- Status last verified
- Mar 2022
- First submitted
- 8 Sep 2020
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. 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 in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04570228
- Acronym / sponsor ID
- CLNS03-001 - TROPHY 3 Protocol
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- SoniVie Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 30 Sep 2020 (actual)
- 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.
Theis is a prospective, multicenter, blinded, randomized sham controlled pivotal clinical trial with a crossover at 6M, to assess the safety and effectiveness of pulmonary artery denervation with the TIVUS™ System in subjects with PAH. The study will assess improved and/or maintained exercise tolerance in patients with PAH through the analysis of exercise tolerance, hemodynamic changes, clinical worsening and the quality of life who got treated by the TIVUS system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 2:1 with a sham controlled arm, with subjects and all follow up staff blinded to the subject treatment. Subjects will be unblinded at 6M, and sham control group will be offered treatment at this time if they meet the inclusion/ exclusion criteria. The primary effectiveness endpoint is measured at 6 months. The safety endpoint for blinded patients is at 6 months, and for treated patients again at 12 months.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Active comparator | Device: Pulmonary artery denervationPulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization and pulmonary artery angiography. |
| Sham control group | Sham comparator | Device: Sham procedureA sham treatment of pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization pulmonary artery angiography. The sham procedure will be identical to the denervation procedure, with the only exception that the procedure will use a sham setting on the control console. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure.
- Male or female ≥ 18 years of age at the time of screening
- Subject with known pulmonary arterial hypertension (PAH), which has been diagnosed as idiopathic PAH, connective tissue disease PAH, anorexigen induced, familial PAH or corrected congenital heart defects more than 1 year prior to enrollment, confirmed by right heart catheterization performed prior to screening and showing all of the following:
- Subject is on maximally tolerated medical therapy for PAH, as determined by his PAH physician
- Subject 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)
- Subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months
- Subjects with portal-pulmonary hypertension, Group 2, 3 and 4 PH
- Pregnant women or women planning a pregnancy within 12 months of study enrolment
- Subject with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry
- Subject with life expectancy of less than a year
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 |
|---|---|---|
| Pulmonary artery denervationThe TIVUS system will be used for pulmonary artery denervation using non focused ultrasound | Device | Treatment group |
| Sham procedureA sham procedure would be performed using the TIVUS system without delivering the non focused ultrasound | Device | Sham control group |
Primary outcome
6 minute walking distance (6MWD)
Time frame: 6 months
Statistical difference in 6MWD between the treated group and the sham control group
The rate of procedure and treatment related SAEs reported
Time frame: 12 months
11 secondary outcomes
Statistical difference between the treated group and the sham control group in exercise tolerance as measured using the change in activity parameters using the Actigraph Centrepoint watch
Time frame: 6 months
Difference between time to clinical worsening event between the treated group and the sham control group
Time frame: 6 months
Difference between the number of clinical worsening events between the treated group and the sham control group
Time frame: 6 months
Difference between the treated group and the sham control group in resting mean right atrial pressure (mRAP)
Time frame: 6 months
Difference between the treated group and the sham control group in resting mean pulmonary artery pressure (mPAP)
Time frame: 6 months
Difference between the treated group and the sham control group in resting pulmonary vascular resistance (PVR)
Time frame: 6 months
Difference between the treated group and the sham control group in resting cardiac index (CI)
Time frame: 6 months
Difference between the treated group and the sham control group in Quality of Life (QOL) score using the SF36 questionnaire
Time frame: 6 months
Difference between the treated group and the sham control group of NT-pro-BNP levels
Time frame: 6 months
Difference between the treated group and the sham control group in patients' clinical pulmonary arterial hypertension condition defined by worsening of World Health Organization (WHO) functional class
Time frame: 6 months
Percent of patients who improve or maintain their exercise tolerance (as measured by 6MWD and actigraphy)
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 1 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary artery denervation in people with Pulmonary Arterial Hypertension, run by SoniVie Inc..
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 10 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Contact Dalit Shav, PhD (+19784600773, info@sonivie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 minute walking distance (6MWD) (time frame: 6 months). The study lists 2 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 1 Apr 2022.