CVRx Barostim Hypertension Pivotal Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by CVRx, Inc.
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.
ClinicalTrials.gov Identifier:
NCT01679132
First received: August 31, 2012
Last updated: August 23, 2013
Last verified: August 2013
  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:


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
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

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

Locations
United States, Arizona
Arizona Heart Rhythm Research Center Recruiting
Phoenix, Arizona, United States, 85006
Contact: Wendy Schwoegler    602-456-2342    wschwoegler@azheartrythm.com   
Principal Investigator: Vijay Swarup         
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, District of Columbia
George Washington University Recruiting
Washington, District of Columbia, United States, 20037
Contact: Cathy Garey    202-741-3168    cgarey@mfa.gwu.edu   
Principal Investigator: Gregory Trachiotis         
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         
Florida Cardiovascular Institute Recruiting
Tampa, Florida, United States, 33606
Contact: Courtney Lee    813-353-8535    courtneyelee@tgh.org   
Principal Investigator: Fadi Matar         
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, Michigan
Cardiac and Vascular Research Center of Northern Michigan Recruiting
Petosky, Michigan, United States, 49770
Contact: Jennifer LaLonde    231-487-9185    jlalonde@cvrcnm.com   
Principal Investigator: Harry Colfer         
Michigan CardioVascular Institute Recruiting
Saginaw, Michigan, United States, 48601
Contact: Tacey Gauthier    989-907-8031    tgauthier@mcvi.com   
Principal Investigator: Naveed Akhtar         
United States, Nevada
University Medical Center of Southern Nevada Recruiting
Las Vegas, Nevada, United States, 89102
Contact: Luzviminda Dizon    702-383-2585    luzviminda.dizon@umcsn.com   
Principal Investigator: Chowdhury Ahsan         
United States, Oklahoma
Oklahoma Heart hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Bonnie Miller    405-608-1280    bmiller@okheart.com   
Principal Investigator: Branislov Schifferdecker         
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: August 23, 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 September 16, 2014