Device Based Therapy in Hypertension Extension Trial (DEBuT-HET)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study|
- 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 ]
|Study Start Date:||August 2005|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Device: CVRx Rheos Baroreflex Hypertension Therapy System
- Rheos Hypertension Therapy
- Baroreflex Activation Therapy™ (BAT™)
- Baroreflex Hypertension Therapy
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.
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.
|University Hospital Bad Oeynhausen|
|Bad Oeynhausen, Germany|
|Charité Campus Buch|
|University Hospital Hannover|
|Academisch Ziekenhuis Maastricht|
|Study Chair:||Myriah Elletson||CVRx, Inc.|