Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2025-12-16 @ 11:36 PM
Study NCT ID:
NCT04570228
Status:
None
Last Update Posted:
2022-04-01 00:00:00
First Post:
2020-09-08 00:00:00
Brief Title:
TROPHY PAH Pivotal Study - TReatment of Pulmonary HYpertension for PAH Pivotal Study
Sponsor:
SoniVie Inc
Organization:
SoniVie Inc.
Study Overview
Official Title:
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Pulmonary Artery Denervation in Patients With Pulmonary Arterial Hypertension
Status:
None
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None