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BAROSTIM NEO Hypertension Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01679132
Recruitment Status : Suspended (Company resources only allows adequate oversight for one pivotal trial at a time)
First Posted : September 5, 2012
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
CVRx, Inc.

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date September 10, 2019
Study Start Date  ICMJE April 12, 2013
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2019)
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. [ Time Frame: For the duration of the study, up to ten years. ]
Ascertain the type, frequency, severity and timing of long-term adverse events in G120137 study subjects implanted with the device, while providing a viable treatment option to patients currently implanted with the CVRx BAROSTIM NEO System.
Original Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
  • 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 ]
  • To demonstrate a significant reduction of BpTRU systolic blood pressure (SBP) at 3 months post activation. [ Time Frame: 3 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
  • To demonstrate a significant reduction of BpTRU systolic blood pressure (SBP) at 6 months post activation. [ Time Frame: 6 months ]
  • To demonstrate a significant reduction of 24-hour ambulatory systolic blood pressure (SBP) at 6 months post-activation. [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAROSTIM NEO Hypertension Pivotal Trial
Official Title  ICMJE BAROSTIM NEO Hypertension Pivotal Trial
Brief Summary The purpose of this clinical investigation (NCT01679132) is to assess the long-term safety and efficacy of the BAROSTIM NEO System in subjects currently participating in the BAROSTIM Hypertension Pivotal Trial (G120137).
Detailed Description

The BAROSTIM NEO Hypertension Trial is a prospective, randomized, controlled trial assessing the safety and efficacy of the BAROSTIM NEO System in subjects with resistant hypertension.

All subjects are now in long term follow-up and are required to have at least one annual visit.

Parameters assessed during visits are:

  • Office Cuff Blood Pressure
  • Physical Assessment
  • Subject Medications
  • Serious adverse events
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Uncontrolled Hypertension
Intervention  ICMJE Device: BAROSTIM NEO System and Medical Management

Experimental: Device and Medical Management

Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators.

Other Name: Neo System
Study Arms  ICMJE Experimental: BAROSTIM NEO System
Subjects implanted with the BAROSTIM NEO System.
Intervention: Device: BAROSTIM NEO System and Medical Management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Actual Enrollment  ICMJE
 (submitted: September 6, 2019)
10
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
600
Estimated Study Completion Date  ICMJE March 2026
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Actively participating in the Barostim Hypertension Pivotal Trial and currently implanted with the BAROSTIM NEO device with the device turned ON.
  • Have signed a revised approved informed consent form for continued participation in this study.

Exclusion Criteria:

  • Treating physician decision that the subject should not continue with therapy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01679132
Other Study ID Numbers  ICMJE 360039
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CVRx, Inc.
Study Sponsor  ICMJE CVRx, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account CVRx, Inc.
Verification Date September 2019

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