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Device Based Therapy in Hypertension Extension Trial

NCT00710294 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2011-10-31

No results posted yet for this study

Summary

This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.

Conditions

Interventions

DEVICE

CVRx Rheos Baroreflex Hypertension Therapy System

The pulse generator, which is similar to a pacemaker, is typically implanted under the skin below the collarbone. Two small leads from the device are wrapped around the carotid arteries on both sides of the neck and connected to the pulse generator.

Sponsors & Collaborators

  • CVRx, Inc.

    lead INDUSTRY

Principal Investigators

  • Myriah Elletson · CVRx, Inc.

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
2005-08-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Germany
  • Netherlands
  • Switzerland

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 NCT00710294 on ClinicalTrials.gov