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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT00710294
First received: July 2, 2008
Last updated: October 28, 2011
Last verified: October 2011
  Purpose

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 Intervention
Hypertension
Device: CVRx Rheos Baroreflex Hypertension Therapy System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: August 2005
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00710294

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

Additional Information:
No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT00710294     History of Changes
Other Study ID Numbers: 360007-001
Study First Received: July 2, 2008
Last Updated: October 28, 2011
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014