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BAROSTIM NEO Hypertension Pivotal Trial

Primary Purpose

Uncontrolled Hypertension

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
BAROSTIM NEO System and Medical Management
Sponsored by
CVRx, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uncontrolled Hypertension

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Arizona Heart Rhythm Research Center
  • University of Southern California
  • George Washington University
  • Florida Hospital
  • Tampa General Hospital
  • Cardiovascular Institute of the South
  • Cardiac and Vascular Research Center of Northern Michigan
  • Michigan CardioVascular Institute
  • University Medical Center of Southern Nevada
  • Allegheny General Hospital
  • Aspirus Wausau Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BAROSTIM NEO System

Arm Description

Subjects implanted with the BAROSTIM NEO System.

Outcomes

Primary Outcome Measures

To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
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.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2012
Last Updated
April 18, 2023
Sponsor
CVRx, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01679132
Brief Title
BAROSTIM NEO Hypertension Pivotal Trial
Official Title
BAROSTIM NEO Hypertension Pivotal Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Suspended
Why Stopped
Company resources only allows adequate oversight for one pivotal trial at a time
Study Start Date
April 12, 2013 (undefined)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CVRx, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uncontrolled Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BAROSTIM NEO System
Arm Type
Experimental
Arm Description
Subjects implanted with the BAROSTIM NEO System.
Intervention Type
Device
Intervention Name(s)
BAROSTIM NEO System and Medical Management
Other Intervention Name(s)
Neo System
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
Description
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.
Time Frame
For the duration of the study, up to ten years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Bakris, MD
Organizational Affiliation
The University of Chicago Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Bisognano, MD
Organizational Affiliation
University of Rochester
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fred Weaver, MD
Organizational Affiliation
Keck School of Medicine of the University of Southern California
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
William Abraham, MD
Organizational Affiliation
Ohio State University
Official's Role
Study Chair
Facility Information:
Facility Name
Arizona Heart Rhythm Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
George Washington University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cardiovascular Institute of the South
City
Houma
State/Province
Louisiana
ZIP/Postal Code
70360
Country
United States
Facility Name
Cardiac and Vascular Research Center of Northern Michigan
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
Michigan CardioVascular Institute
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Aspirus Wausau Hospital
City
Wausau
State/Province
Wisconsin
ZIP/Postal Code
54401
Country
United States

12. IPD Sharing Statement

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BAROSTIM NEO Hypertension Pivotal Trial

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