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Continued Safety and Performance of the TIVUS System

NCT01835535 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-03-26

No results posted yet for this study

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

DEVICE

TIVUS

Sponsors & Collaborators

  • Cardiosonic

    lead INDUSTRY

Principal Investigators

  • Michael Jonas, MD · Kaplan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-06-30
Completion
2016-12-31

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01835535 on ClinicalTrials.gov