Device Based Therapy in Hypertension Extension Trial (DEBuT-HET)
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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.
Condition or disease
Device: CVRx Rheos Baroreflex Hypertension Therapy System
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.
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 ]
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Ages Eligible for Study:
21 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Are unable to comply with protocol requirements.
Are enrolled in another concurrent clinical trial.