Device Based Therapy in Hypertension Extension Trial - Full Text View

Sponsored by:	CVRx, Inc.
Information provided by:	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT00710294

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

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study

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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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

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:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	CVRx ( CVRx )
Study ID Numbers:	360007-001
Study First Received:	July 2, 2008
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00710294 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by CVRx, Inc.:

Refractory Hypertension
High Blood Pressure
Uncontrolled Blood Pressure

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009