NCT00710294

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable hypertension

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 4, 2008

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

6.2 years

First QC Date

July 2, 2008

Last Update Submit

October 28, 2011

Conditions

Hypertension

Keywords

Refractory HypertensionHigh Blood PressureUncontrolled Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

CVRx Rheos Baroreflex Hypertension Therapy SystemDEVICE

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.

Also known as: Rheos Hypertension Therapy, Baroreflex Activation Therapy™ (BAT™), Baroreflex Hypertension Therapy

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University Hospital Bad Oeynhausen

Bad Oeynhausen, Germany

Location

Charité Campus Buch

Berlin, Germany

Location

University Hospital Hannover

Hanover, Germany

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Inselspital Bern

Bern, Switzerland

Location

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Myriah Elletson

    CVRx, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2008

First Posted

July 4, 2008

Study Start

August 1, 2005

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

DE(3)NL(1)CH(1)