Device Based Therapy in Hypertension Extension Trial

Hypertension Clinical Trial

— DEBuT-HET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00710294
• Other study ID #: 360007-001
• Status: Completed
• Phase: N/A
• First received: July 2, 2008
• Last updated: October 28, 2011
• Start date: August 2005
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: CVRx, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Germany	University Hospital Bad Oeynhausen	Bad Oeynhausen
Germany	Charité Campus Buch	Berlin
Germany	University Hospital Hannover	Hannover
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
Switzerland	Inselspital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
CVRx, Inc.

Countries where clinical trial is conducted

Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes

External Links

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