MedTrace Logo

Rheos Feasibility Trial

NCT01077180 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-02

No results posted yet for this study

Summary

The Rheos Feasibility Trial is designed to assess safety, device performance, and protocol parameters of the CVRx Rheos Baroreflex Therapy in patients with severe hypertension that are refractory to full drug therapy.

Conditions

Interventions

DEVICE

Implantation of the Rheos System

Open label

OTHER

Standard of care medical management

Patients will continue with medical therapy for standard of care of their hypertension.

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2007-12-31
Completion
2010-10-31
FDA Device
Yes

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 NCT01077180 on ClinicalTrials.gov