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Device Based Therapy in Hypertension Extension Trial

NCT ID: NCT00710294

Last Updated: 2011-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension

Keywords

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Refractory Hypertension High Blood Pressure Uncontrolled Blood Pressure

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Rheos Hypertension Therapy Baroreflex Activation Therapy™ (BAT™) Baroreflex Hypertension Therapy

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CVRx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Myriah Elletson

Role: STUDY_CHAIR

CVRx, Inc.

Locations

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University Hospital Bad Oeynhausen

Bad Oeynhausen, , Germany

Site Status

Charité Campus Buch

Berlin, , Germany

Site Status

University Hospital Hannover

Hanover, , Germany

Site Status

Academisch Ziekenhuis Maastricht

Maastricht, , Netherlands

Site Status

Inselspital Bern

Bern, , Switzerland

Site Status

Countries

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Germany Netherlands Switzerland

Related Links

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http://www.cvrx.com

Related Info

Other Identifiers

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360007-001

Identifier Type: -

Identifier Source: org_study_id