CVRx Barostim Hypertension Pivotal Trial - Full Text View

Purpose

The Barostim™ Hypertension Pivotal Trial is a prospective, randomized, controlled trial to demonstrate the safety and efficacy of the Barostim Neo system in subjects with resistant hypertension.

Condition	Intervention
Uncontrolled Hypertension	Device: Neo Baroreflex Activation Therapy System Other: Standard of care medical management only


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	CVRx Barostim Hypertension Pivotal Trial

Further study details as provided by CVRx, Inc.:

Primary Outcome Measures:

Primary Safety Objective [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
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.
Primary Efficacy Objective [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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:

Secondary Efficacy Objective 1 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To demonstrate a significant reduction within the device arm of office cuff systolic blood pressure (SBP) between baseline and 12 months post-activation.
Secondary Efficacy Objective 2 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To demonstrate a significant reduction within the device arm of 24-hour ambulatory systolic blood pressure (SBP) between baseline and 12 months post-activation.
Secondary Safety Objective [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.


Estimated Enrollment:	310
Study Start Date:	January 2013
Estimated Study Completion Date:	September 2017
Estimated Primary Completion Date:	September 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	21 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01679132

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 Cardiovascular Institute
Orlando, Florida, United States, 32803
Florida Cardiovascular Institute
Tampa, Florida, United States, 33606
United States, Louisiana
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70361
United States, Michigan
Cardiac and Vascular Research Center of Northern Michigan
Petosky, 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, Oklahoma
Oklahoma Heart hospital
Oklahoma City, Oklahoma, United States, 73120
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


Responsible Party:	CVRx, Inc.
ClinicalTrials.gov Identifier:	NCT01679132 History of Changes
Other Study ID Numbers:	360039
Study First Received:	August 31, 2012
Last Updated:	September 2, 2016
Health Authority:	United States: Food and Drug Administration

Keywords provided by CVRx, Inc.:


Hypertension High Blood Pressure Blood Pressure Cardiovascular Disease Resistant Hypertension

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2016