NCT00710294

Device Based Therapy in Hypertension Extension Trial

DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Hypertension

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-08-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2008-07-04
• Last updated: 2011-10-31

Locations

5 sites across 3 countries: Germany, Netherlands, Switzerland