Ignite Creation Date:
2024-05-06 @ 8:50 AM
Last Modification Date:
2024-10-26 @ 12:06 PM
Study NCT ID:
NCT02835950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-21
First Post:
2016-07-10
Brief Title:
TReatment Of Pulmonary HYpertension 1-US 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 PDN in Patients With Pulmonary Hypertension - US
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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:
TROPHY 1-US
Brief Summary:
The objective of this study is to assess the safety performance and initial effectiveness of the TIVUS System when used for pulmonary artery denervation through subjective and objective change in clinical parameters and haemodynamic evaluation This is a prospective multi-center non-randomized open-label clinical trail The study will be conducted in up to 4 centers and will recruit up to 15 patients diagnosed with PAH functional class III who have stable PAH on a stable drug regimen of two pulmonary arterial hypertension specific medications
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