Device Based Therapy in Hypertension Extension Trial (DEBuT-HET)

October 28, 2011 updated by: CVRx, Inc.

DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the DEBuT-HT study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the DEBuT-HT trial. Annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Oeynhausen, Germany
        • University Hospital Bad Oeynhausen
      • Berlin, Germany
        • Charite Campus Buch
      • Hannover, Germany
        • University Hospital Hannover
  • Netherlands
      • Maastricht, Netherlands
        • Academisch Ziekenhuis Maastricht
  • Switzerland
      • Bern, Switzerland
        • Inselspital Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Have completed the follow-up period (4-month or longer) of the DEBuT-HT trial (protocol No.: 360004-001)
  • Have signed an approved informed consent form for participation in this study

Exclusion Criteria:

  • Are unable to comply with protocol requirements.
  • Are enrolled in another concurrent clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Describe the safety of Rheos Baroreflex Hypertension Therapy System by evaluating all adverse events and estimating the system and procedure related adverse event rate until and including the 13-month follow-up.
Time Frame: after last 13-month follow-up
after last 13-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CVRx, Inc.

Investigators

  • Study Chair: Myriah Elletson, CVRx, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (ESTIMATE)

July 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2011

Last Update Submitted That Met QC Criteria

October 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 360007-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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