BAROSTIM NEO Hypertension Pivotal Trial

The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).

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Key information

Conditions

Uncontrolled Hypertension

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona Heart Rhythm Research Center, Phoenix, Arizona, United States

About this study

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

Office Cuff Blood Pressure
Physical Assessment
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 Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
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 and Medical Management

Device

Experimental: Device and Medical Management

Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.

Other names: Neo System

Primary outcomes

To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.

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

Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.

Sponsors and collaborators

Lead sponsor

CVRx, Inc.

Industry

Registry information

Important dates

Study start: 2013
Primary completion: 2025
Study completion: 2025
First posted: Sep 5, 2012
Registry last updated: Sep 11, 2026

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.

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

Completed