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

• 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 ] [ Designated as safety issue: Yes ]
  

Device: 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.

Other Names:
• Rheos Hypertension Therapy
• Baroreflex Activation Therapy™ (BAT™)
• Baroreflex Hypertension Therapy

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.