Device Based Therapy in Hypertension Extension Trial

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bad Oeynhausen, Bad Oeynhausen, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CVRx Rheos Baroreflex Hypertension Therapy System

Device

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 outcomes

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

Sponsors and collaborators

Lead sponsor

CVRx, Inc.

Industry

Registry information

Official study title

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

Acronym: DEBuT-HET

Important dates

Study start: 2005
Primary completion: 2011
Study completion: 2011
First posted: Jul 4, 2008
Registry last updated: Oct 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed