BAROSTIM NEO HTN Pivotal Trial

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The BAROSTIM NEO HTN trial is a prospective, randomized, controlled trial to demonstrate the safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.

Currently, the BAROSTIM NEO HTN trial is not actively enrolling. CVRx is conducting long-term follow-up of patients implanted with the BAROSTIM NEO device. This update was not done for any subject protection concerns that would preclude continuation of the investigation.

Condition or disease	Intervention/treatment	Phase
Uncontrolled Hypertension	Device: Neo Baroreflex Activation Therapy System; Other: Standard of care medical management only	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	310 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Masking Description:	Open Label
Primary Purpose:	Treatment
Official Title:	CVRx BAROSTIM NEO Hypertension Pivotal Trial
Study Start Date :	January 2013
Estimated Primary Completion Date :	September 2020
Estimated Study Completion Date :	September 2020

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Neo Baroreflex Activation Therapy System; Patients are randomized to receive Neo Baroreflex Activation Therapy System device plus optimal medical management.	Device: Neo Baroreflex Activation Therapy System; Other Names: Neo System; Barostim Neo System
Active Comparator: Medical Management Arm; Patients are randomized to receive optimal medical management alone.	Other: Standard of care medical management only; Patients will continue with medical therapy for standard of care of their hypertension.

Outcome Measures

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Primary Outcome Measures :

1. Primary Safety Objective [ Time Frame: 30 days ]
   To demonstrate the safety of the Neo system by reporting all adverse events that are complications between implant and 30 days post-implant in the device arm. The incidence of adverse events will be categorized by relatedness.
2. Primary Efficacy Objective [ Time Frame: 6 months ]
   To demonstrate a significant reduction between the two treatment arms of protocol defined automated office cuff systolic blood pressure (SBP) from baseline to 6 months post-activation.

Secondary Outcome Measures :

1. Secondary Efficacy Objective 1 [ Time Frame: 12 months ]
   To demonstrate a significant reduction within the device arm of office cuff systolic blood pressure (SBP) between baseline and 12 months post-activation.
2. Secondary Efficacy Objective 2 [ Time Frame: 12 months ]
   To demonstrate a significant reduction within the device arm of 24-hour ambulatory systolic blood pressure (SBP) between baseline and 12 months post-activation.
3. Secondary Safety Objective [ Time Frame: 6 months ]
   To demonstrate the safety of the Neo system by reporting all hypertensive emergencies from activation to 6 months post activation. The incidence of hypertensive emergencies will be categorized by study arm.

Eligibility Criteria

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

Criteria

Inclusion Criteria Highlights:

• Age at least 21 years and no more than 80 years at the time of randomization.
• On four or more maximally tolerated anti-hypertensive medications, one of which is a diuretic. The antihypertensive medication regimen must remain unchanged for 4 weeks prior to screening and must be expected to remain unchanged for at least 6 months during follow-up.
• Protocol defined systolic blood pressure greater than or equal to 160 mmHg.
• Protocol defined 24-hour Ambulatory Blood Pressure Monitoring (ABPM) greater than or equal to 135 mmHg.
• Serum estimated glomerular filtration rate (eGFR) > 29 mL/min/1.73 m^2.
• Appropriate surgical candidate.
• Women of childbearing potential must use a medically accepted method of birth control and agree to continue use of this method for the duration of the study. Women of childbearing potential must have a negative pregnancy test within 14 days prior to randomization.

Exclusion Criteria Highlights:

• Known or suspected baroreflex failure or autonomic neuropathy.
• Myocardial infarction, hypertensive crisis, symptomatic orthostatic hypotension, unstable angina, syncope, or cerebral vascular accident within the 3 months.
• Hypertension secondary to an identifiable and treatable cause other than sleep apnea.
• Prior surgery, radiation, or endovascular stent placement in the carotid sinus region.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT01679132 History of Changes
Other Study ID Numbers:	360039
First Posted:	September 5, 2012
Last Update Posted:	February 28, 2018
Last Verified:	February 2018

Keywords provided by CVRx, Inc.:

Hypertension; High Blood Pressure; Blood Pressure; Cardiovascular Disease; Resistant Hypertension

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases