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

CVRx

Status

Completed

Conditions

Hypertension

Treatments

Device: CVRx Rheos Baroreflex Hypertension Therapy System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00710294

360007-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No 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