NCT00710190

Device Based Therapy in Hypertension Trial

A Study of Baroreflex Hypertension Therapy in Refractory Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the safety and efficacy of the Rheos Baroreflex Hypertension Therapy System in patients with refractory hypertension.

Detailed description

The DEBuT-HT trial will investigate the safety and efficacy of Rheos Baroreflex Hypertension Therapy(TM) in patients with refractory hypertension despite full pharmacologic therapy. Enrolled patients will be carefully assessed prior to receiving a permanently implanted Rheos System. Once the system is implanted, these patients will be followed closely for 1 month to establish baseline information. The Rheos System will be programmed "ON" at the 1 month follow-up and incrementally increased at 2 and 3-month follow-up evaluations. An assessment of safety and efficacy will be made at the 4-month follow-up. Enrolled patients will be followed annually thereafter.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Rheos Baroreflex Hypertension Therapy System	This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.

Timeline

• Start date: 2003-07-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2008-07-04
• Last updated: 2016-10-21

Locations

9 sites across 6 countries: Czechia, Germany, Latvia, Netherlands, Poland, Switzerland