TROPHY PAH Pivotal Study - TReatment of Pulmonary HYpertension for PAH Pivotal Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Written informed consent to participate in the study obtained from the subject, according to local regulations, prior to initiation of any study mandated procedure. 2. Male or female ≥ 18 years of age at the time of screening 3. 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) 4.
Subject is on maximally tolerated medical therapy for PAH, as determined by his PAH physician 5. 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) 6. Subject is able to tolerate IV contrast used for the angiograms during treatment 7. Subject is WHO functional class II or III

Exclusion Criteria:

1. Subject is treated with parenteral prostanoids and has not been on a stable dose for at least 3 months 2. Subjects with portal-pulmonary hypertension, Group 2, 3 and 4 PH 3. Pregnant women or women planning a pregnancy within 12 months of study enrolment 4. Subject with significant co-morbid conditions which, at the discretion of the PI, are deemed to prohibit study entry 5. Subject with life expectancy of less than a year 6. Concurrent enrollment in another device or drug trial except for observational studies (unless specifically approved by the sponsor) 7. Subject with pulmonary artery anatomy that precludes treatment with the TIVUS System 8. Subject who has experienced a myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 6 months 9. Subject experiencing a current episode of acute decompensated heart failure 10. Subject who has cardiac pacemakers/ICD/CRT-D that were implanted fewer than three months prior to enrollment. 11. Subject who has implantable Cardiomems device, or other implanted device that might be contraindicated for therapeutic ultrasound energy.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04570228
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

SoniVie Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

Active Comparator: Treatment group

Pulmonary artery denervation with the TIVUS™ System will be performed immediately after the right heart catheterization and pulmonary artery angiography.

Sham Comparator: Sham control group

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.

Interventions

Device: - Pulmonary artery denervation

The TIVUS system will be used for pulmonary artery denervation using non focused ultrasound

Device: - Sham procedure

A sham procedure would be performed using the TIVUS system without delivering the non focused ultrasound

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Dalit Shav, PhD

info@sonivie.com

+19784600773

For additional contact information, you can also visit the trial on clinicaltrials.gov.

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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