Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT01471834

Verification of the Efficacy and Safety of the BAROSTIM NEO System in the Treatment of Drug Resistant Hypertension

To assess the long-term safety and efficacy of the BAROSTIM NEO System in trial (NCT01471834) participants.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

High Blood Pressure Cardiovascular Diseases Hypertension Vascular Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

The Neo Non-Randomized Hypertension Study is a non-randomized, open-label, verification study in participants diagnosed with drug resistant hypertension, defined as medical treatment failure for hypertension defined as office cuff systolic blood pressure (SBP) ≥ 140 mmHg despite being prescribed to at least three antihypertensive medications, including a diuretic, in accordance with the AHA guidelines.

Participants should remain on their prescribed anti-hypertensive medications and same dosing schedule for the duration of the study unless investigators determine medically necessary changes are needed. Additionally, every effort should be made to maintain adequate rate control for subjects with atrial fibrillation throughout the duration of the study.

All (Canadian) participants are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during long-term follow-up visits:

  • Physical Assessment
  • Office Cuff Blood Pressure
  • Subject Medications
  • Serious adverse events

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Actively participating in the Neo Non-Randomized Hypertension Study.
  • Have signed a revised approved informed consent form for continued participation in this study.

Exclusion criteria

  • Treating physician decision that the subject should not continue with therapy.

Treatment and study plan

BAROSTIM NEO System

Device

Other names: XR-1 System, Neo System

Medical Management

Drug

Primary outcomes

  1. To access long-term adverse events in participants implanted with the BAROSTIM NEO System.

    Time frame: For the duration of the study, up to 10 years.

    Ascertain the type, frequency, severity and timing of long-term adverse events in participants implanted with the device, while providing a viable treatment option to participants currently implanted with CVRx's BAROSTIM NEO System.

Sponsors and collaborators

Lead sponsor

CVRx, Inc.

Industry

Registry information

Official study title

Neo Non-Randomized Hypertension Study

Important dates

Study start
2011
Primary completion
2012
Study completion
2026
First posted
Nov 16, 2011
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.