NCT04570228

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

Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: SoniVie Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-01
• Completion: 2025-12-01
• First posted: 2020-09-30
• Last updated: 2022-04-01

Regulatory

• FDA-regulated device study