BAROSTIM NEO HTN Pivotal Trial
|ClinicalTrials.gov Identifier: NCT01679132|
Recruitment Status : Suspended (Study was suspended as company resources will only allow adequate oversight for one pivotal trial at a time.)
First Posted : September 5, 2012
Last Update Posted : February 28, 2018
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|
|Uncontrolled Hypertension||Device: Neo Baroreflex Activation Therapy System Other: Standard of care medical management only|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||310 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|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|
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
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.
- 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.
- 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 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01679132
|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|
|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|
|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|