BAROSTIM NEO Hypertension Pivotal Trial

NCT ID: NCT01679132

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-12

Study Completion Date

2026-03-31

Brief Summary

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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).

Detailed Description

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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

Conditions

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Uncontrolled Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BAROSTIM NEO System

Subjects implanted with the BAROSTIM NEO System.

Group Type EXPERIMENTAL

BAROSTIM NEO System and Medical Management

Intervention Type 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.

Interventions

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BAROSTIM NEO System and Medical Management

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.

Intervention Type DEVICE

Other Intervention Names

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Neo System

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CVRx, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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George Bakris, MD

Role: STUDY_CHAIR

The University of Chicago Medicine

John Bisognano, MD

Role: STUDY_CHAIR

University of Rochester

Fred Weaver, MD

Role: STUDY_CHAIR

Keck School of Medicine of the University of Southern California

William Abraham, MD

Role: STUDY_CHAIR

Ohio State University

Locations

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Arizona Heart Rhythm Research Center

Phoenix, Arizona, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

George Washington University

Washington D.C., District of Columbia, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Tampa General Hospital

Tampa, Florida, United States

Site Status

Cardiovascular Institute of the South

Houma, Louisiana, United States

Site Status

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, United States

Site Status

Michigan CardioVascular Institute

Saginaw, Michigan, United States

Site Status

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Aspirus Wausau Hospital

Wausau, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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360039

Identifier Type: -

Identifier Source: org_study_id

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