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Continued Safety and Performance of the TIVUS System

Hypertension, Resistant to Conventional Therapy Clinical Trial

Official title:
Clinical Evaluation of the Therapeutic Intra-Vascular Ultrasound (TIVUS™) System for Renal Denervation in Patients With Resistant Hypertension

Clinical Trial Summary

The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts:

- TIVUS™ Severe Resistant HTN Cohort

- TIVUS™ Moderate Resistant HTN Cohort

- TIVUS™ Failed RF Therapy Cohort

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01835535
Study type Interventional
Source Cardiosonic
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date August 2013
Completion date December 2016
View Details
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