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BAROSTIM NEO Hypertension Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679132
Recruitment Status : Suspended (Company resources only allows adequate oversight for one pivotal trial at a time)
First Posted : September 5, 2012
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Study Description
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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
Uncontrolled Hypertension Device: BAROSTIM NEO System and Medical Management Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : April 12, 2013
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : March 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Neo System


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679132


Locations
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United States, Arizona
Arizona Heart Rhythm Research Center
Phoenix, Arizona, United States, 85006
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States, 20037
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32803
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
United States, Michigan
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States, 49770
Michigan CardioVascular Institute
Saginaw, Michigan, United States, 48601
United States, Nevada
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
United States, Pennsylvania
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Wisconsin
Aspirus Wausau Hospital
Wausau, Wisconsin, United States, 54401
Sponsors and Collaborators
CVRx, Inc.
Investigators
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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
More Information
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Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01679132    
Other Study ID Numbers: 360039
First Posted: September 5, 2012    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases