NCT01835535

Continued Safety and Performance of the TIVUS System

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Cardiosonic · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertension, Resistant to Conventional Therapy

Interventions

Type	Name	Description
DEVICE	TIVUS

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-06-01
• Completion: 2016-12-01
• First posted: 2013-04-19
• Last updated: 2014-03-26

Locations

1 site across 1 country: Australia