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

SoniVie

Status: Not yet enrolling

Conditions: Pulmonary Arterial Hypertension

Treatments: Device: Pulmonary artery denervation; Device: Sham procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04570228

CLNS03-001 - TROPHY 3 Protocol

Details and patient eligibility

About

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.

Enrollment: 205 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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205 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

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

Treatment:

Device: Pulmonary artery denervation

Sham control group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham procedure