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).

Study Overview

• Status: Suspended
• Conditions: Uncontrolled Hypertension
• Intervention / Treatment: Device: BAROSTIM NEO System and Medical Management

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Arizona Heart Rhythm Research Center
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • George Washington University
  • Florida
    • Orlando, Florida, United States, 32803
      • Florida Hospital
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Louisiana
    • Houma, Louisiana, United States, 70360
      • Cardiovascular Institute of the South
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Cardiac and Vascular Research Center of Northern Michigan
    • Saginaw, Michigan, United States, 48601
      • Michigan Cardiovascular Institute
  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • University Medical Center of Southern Nevada
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Wisconsin
    • Wausau, Wisconsin, United States, 54401
      • Aspirus Wausau Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: BAROSTIM NEO System; Subjects implanted with the BAROSTIM NEO System.

Device: 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.; Other Names: Neo System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.	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.	For the duration of the study, up to ten years.

Collaborators and Investigators

• Sponsor: CVRx, Inc.
• Investigators: Study Chair: George Bakris, MD, The University of Chicago Medicine; Study Chair: John Bisognano, MD, University of Rochester; Study Chair: Fred Weaver, MD, Keck School of Medicine of the University of Southern California; Study Chair: William Abraham, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start: April 12, 2013
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: August 31, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimated): September 5, 2012

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: 360039

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes