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

NCT04570228 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2022-04-01

No results posted yet for this study

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. 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

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

Sponsors & Collaborators

  • SoniVie Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-12-01
Completion
2025-12-01
FDA Device
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04570228 on ClinicalTrials.gov