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

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ClinicalTrials.gov Identifier: NCT00710294
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : October 31, 2011
Information provided by (Responsible Party):
CVRx, Inc.

Brief 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.

Condition or disease Intervention/treatment
Hypertension Device: CVRx Rheos Baroreflex Hypertension Therapy System

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study
Study Start Date : August 2005
Primary Completion Date : October 2011
Study Completion Date : October 2011

Intervention Details:
    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.

    Other Names:
    • Rheos Hypertension Therapy
    • Baroreflex Activation Therapy™ (BAT™)
    • Baroreflex Hypertension Therapy

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00710294

University Hospital Bad Oeynhausen
Bad Oeynhausen, Germany
Charité Campus Buch
Berlin, Germany
University Hospital Hannover
Hannover, Germany
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands
Inselspital Bern
Bern, Switzerland
Sponsors and Collaborators
CVRx, Inc.
Study Chair: Myriah Elletson CVRx, Inc.

Additional Information:
Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00710294     History of Changes
Other Study ID Numbers: 360007-001
First Posted: July 4, 2008    Key Record Dates
Last Update Posted: October 31, 2011
Last Verified: October 2011

Keywords provided by CVRx, Inc.:
Refractory Hypertension
High Blood Pressure
Uncontrolled Blood Pressure

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases