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CVRx Barostim Hypertension Pivotal Trial

This study is currently recruiting participants.
Verified May 2013 by CVRx, Inc.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01679132
First received: August 31, 2012
Last updated: May 16, 2013
Last verified: May 2013
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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: July 2015
Estimated Primary Completion Date: July 2015 (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
No Intervention: Medical Management Arm
Patients are randomized to receive optimal medical management alone.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01679132

Contacts
Contact: Tom Moore 763-416-2352 tmoore@cvrx.com

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Christian Romero     323-442-5322     romeroch@usc.edu    
Principal Investigator: Karen Woo            
United States, Florida
Florida Hospital Cardiovascular Institute Recruiting
Orlando, Florida, United States, 32803
Contact: Carol Stastny     407-303-5600 ext 1103439     carol.stastny@flhosp.org    
Principal Investigator: Harischandra Karunaratne            
United States, Louisiana
Cardiovascular Institute of the South Recruiting
Houma, Louisiana, United States, 70361
Contact: Deanna Benoit     985-873-5613     deanna.benoit@cardio.com    
Principal Investigator: Richard Abben            
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Sheila Bernardini     412-359-5600 ext 1103439     sbernard@wpahs.org    
Principal Investigator: Srinivas Murali            
United States, Wisconsin
Aspirus Wausau Hospital Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Jeff Kaliebe     715-847-2273 ext 52639     jeff.kaliebe@aspirus.org    
Principal Investigator: German Larrain            
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

No publications provided

Responsible Party: CVRx, Inc.
ClinicalTrials.gov Identifier: NCT01679132     History of Changes
Other Study ID Numbers: 360039
Study First Received: August 31, 2012
Last Updated: May 16, 2013
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 May 16, 2013