Device Based Therapy in Hypertension Extension Trial

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT00710294
• Lead Sponsor: CVRx, Inc.

Brief 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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-07-02
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-28
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

• Are unable to comply with protocol requirements.
• Are enrolled in another concurrent clinical trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	after last 13-month follow-up

Trial Locations

Locations (5)

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

Inselspital Bern; 🇨🇭 Bern, Switzerland

Charité Campus Buch; 🇩🇪 Berlin, Germany

University Hospital Hannover; 🇩🇪 Hannover, Germany

University Hospital Bad Oeynhausen; 🇩🇪 Bad Oeynhausen, Germany