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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

August 31, 2012
August 23, 2013
January 2013
July 2015   (final data collection date for primary outcome measure)
  • 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.
  • To demonstrate the safety of the Neo system by evaluating the Type 1 system and procedure related complication free rate through 30 days post-procedure. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • To demonstrate a significant reduction of BpTRU systolic blood pressure (SBP) at 3 months post activation. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01679132 on ClinicalTrials.gov Archive Site
  • 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.
  • To demonstrate a significant reduction of BpTRU systolic blood pressure (SBP) at 6 months post activation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To demonstrate a significant reduction of 24-hour ambulatory systolic blood pressure (SBP) at 6 months post-activation. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
CVRx Barostim Hypertension Pivotal Trial
CVRx Barostim Hypertension Pivotal Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Uncontrolled Hypertension
Device: Neo Baroreflex Activation Therapy System
Other Names:
  • Neo System
  • Barostim Neo System
  • Experimental: Neo Baroreflex Activation Therapy System
    Patients are randomized to receive Neo Baroreflex Activation Therapy System device plus optimal medical management.
    Intervention: Device: Neo Baroreflex Activation Therapy System
  • No Intervention: Medical Management Arm
    Patients are randomized to receive optimal medical management alone.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
310
July 2015
July 2015   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact: Tom Moore 763-416-2352 tmoore@cvrx.com
United States
 
NCT01679132
360039
Yes
CVRx, Inc.
CVRx, Inc.
Not Provided
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
CVRx, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP