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BAROSTIM NEO Hypertension Pivotal Trial

Sponsor
CVRx, Inc. (Industry)
Overall Status
Suspended
CT.gov ID
NCT01679132
Collaborator
(none)
10
Enrollment
11
Locations
1
Arm
154.6
Duration (Months)
0.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Device: BAROSTIM NEO System and Medical Management
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
BAROSTIM NEO Hypertension Pivotal Trial
Study Start Date :
Apr 12, 2013
Anticipated Primary Completion Date :
Mar 1, 2026
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Heart Rhythm Research Center Phoenix Arizona United States 85006
    2 University of Southern California Los Angeles California United States 90033
    3 George Washington University Washington District of Columbia United States 20037
    4 Florida Hospital Orlando Florida United States 32803
    5 Tampa General Hospital Tampa Florida United States 33606
    6 Cardiovascular Institute of the South Houma Louisiana United States 70360
    7 Cardiac and Vascular Research Center of Northern Michigan Petoskey Michigan United States 49770
    8 Michigan CardioVascular Institute Saginaw Michigan United States 48601
    9 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
    10 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    11 Aspirus Wausau Hospital Wausau Wisconsin United States 54401

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CVRx, Inc.
    ClinicalTrials.gov Identifier:
    NCT01679132
    Other Study ID Numbers:
    • 360039
    First Posted:
    Sep 5, 2012
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Additional relevant MeSH terms:
    Hypertension

    Study Results

    No Results Posted as of Dec 1, 2021