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Rheos® Pivotal Trial

NCT00442286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 591

Last updated 2017-03-20

Study results available
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Summary

The purpose of this clinical trial is to demonstrate the efficacy and safety of the Rheos system in subjects with hypertension that are resistant to treatment with at least three anti-hypertension agents, one of which is a diuretic.

Conditions

Interventions

DEVICE

Rheos® Baroreflex Hypertension System

Electrical activation of the Carotid Baroreflex

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Luis Sanchez, MD · Washington University School of Medicine

  • Mitra Nadim, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

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 NCT00442286 on ClinicalTrials.gov