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

Neo Non-Randomized Hypertension Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01471834

Enrollment

Registered

2011-11-16

Start date

2011-06-01

Completion date

2026-12-01

Last updated

2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Blood Pressure

Brief summary

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

Detailed description

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

Interventions

DEVICEBAROSTIM NEO System

DRUGMedical Management

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
To access long-term adverse events in participants implanted with the BAROSTIM NEO System.	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.

Countries

Canada, Germany, Netherlands

Contacts

PRINCIPAL_INVESTIGATORHermann Haller, MD

Hannover Medical School

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026