Device Based Therapy in Hypertension Extension Trial

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00710294

Acronym

DEBuT-HET

Enrollment

Registered

2008-07-04

Start date

2005-08-31

Completion date

2011-10-31

Last updated

2011-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Refractory Hypertension, High Blood Pressure, Uncontrolled Blood Pressure

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.

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.

Interventions

DEVICECVRx 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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.	after last 13-month follow-up

Countries

Germany, Netherlands, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026