NCT00710190

Brief 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.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Jul 2003

Longer than P75 for not_applicable hypertension

Geographic Reach
6 countries

9 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

July 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
3 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 21, 2016

Status Verified

October 1, 2016

Enrollment Period

8.3 years

First QC Date

July 1, 2008

Last Update Submit

October 19, 2016

Conditions

Hypertension

Keywords

Drug Resistant HypertensionRefractory HypertensionHigh Blood PressureBaroreflex Hypertension Therapy

Outcome Measures

Primary Outcomes (2)

  • Demonstrate the safety of Rheos(TM) Baroreflex Hypertension Therapy (TM) System by evaluating all adverse events and estimating the system and procedure related adverse event rate.

    4 months post implant

  • Demonstrate a 10 mmHg decrease from baseline (1-Month office cuff blood pressure) in systolic blood pressure after three months of incrementally optimized therapy.

    4 months post implant

Study Arms (1)

Rheos Implant

EXPERIMENTAL
Device: Rheos Baroreflex Hypertension Therapy System

Interventions

Rheos Baroreflex Hypertension Therapy SystemDEVICE

This therapy uses implantable device-based electrical activation of the carotid sinus baroreflex to control blood pressure.

Rheos Implant

Eligibility Criteria

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

You may qualify if:

  • Be at least 21 years of age.
  • Have been assessed to have bilateral carotid bifurcations located at or below C3 - C4.
  • Have blood pressure greater than or equal to 160 mmHg systolic and/or greater than or equal to 90 mmHg diastolic despite at least two months of full therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic.
  • Must be certified by the investigator as compliant to taking full doses of medications.
  • Have signed an approved informed consent form for participation in this study.

You may not qualify if:

  • Have been diagnosed with:
  • Baroreflex failure or significant orthostatic hypotension
  • Cardiac brady arrhythmias or chronic atrial fibrillation
  • Have carotid atherosclerosis determined by ultrasound or angiographic evaluation with a stenosis of greater than 50%.
  • Have prior surgery or radiation in either carotid sinus region
  • Currently have implanted electrical medical devices such as cardiac pacing, defibrillation or neurologic stimulation systems.
  • Are pregnant or contemplating pregnancy during the 4-month follow-up period.
  • Are on dialysis
  • Have hypertension secondary to a treatable cause
  • Have clinically significant cardiac valvular disease
  • Are unable to comply with protocol requirements.
  • Are unlikely to survive the protocol follow-up period
  • Are enrolled in another concurrent clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

University Hospital Hradec Kralove

Hradec Králové, Czechia

Location

University Hospital Bad Oeynhausen

Bad Oeynhausen, Germany

Location

Charité Campus Buch

Berlin, Germany

Location

Uniklinik Essen

Essen, Germany

Location

University Hospital Hannover

Hanover, Germany

Location

Latvian Centre of Cardiology

Riga, Latvia

Location

Academisch Ziekenhuis Maastricht

Maastricht, Netherlands

Location

Medical University of Gdansk

Gdansk, Poland

Location

Inselspital Bern

Bern, Switzerland

Location

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Thomas Baal, PhD

    CVRx, Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 4, 2008

Study Start

July 1, 2003

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

October 21, 2016

Record last verified: 2016-10

Locations

CZ(1)DE(4)LA(1)NL(1)PL(1)CH(1)