NCT01679132

Brief Summary

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).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

April 12, 2013

Completed
12.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

July 15, 2025

Status Verified

July 1, 2025

Enrollment Period

12.9 years

First QC Date

August 31, 2012

Last Update Submit

July 10, 2025

Conditions

Uncontrolled Hypertension

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

BAROSTIM NEO System

EXPERIMENTAL

Subjects implanted with the BAROSTIM NEO System.

Device: BAROSTIM NEO System and Medical Management

Interventions

BAROSTIM NEO System and Medical ManagementDEVICE

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.

Also known as: Neo System
BAROSTIM NEO System

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Arizona Heart Rhythm Research Center

Phoenix, Arizona, 85006, United States

Location

University of Southern California

Los Angeles, California, 90033, United States

Location

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Cardiac and Vascular Research Center of Northern Michigan

Petoskey, Michigan, 49770, United States

Location

Michigan CardioVascular Institute

Saginaw, Michigan, 48601, United States

Location

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Aspirus Wausau Hospital

Wausau, Wisconsin, 54401, United States

Location

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 5, 2012

Study Start

April 12, 2013

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

July 15, 2025

Record last verified: 2025-07

Locations

US(11)