Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
10 participants
INTERVENTIONAL
2013-04-12
2026-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BAROSTIM NEO System
Subjects implanted with the BAROSTIM NEO System.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have signed a revised approved informed consent form for continued participation in this study.
Exclusion Criteria
21 Years
80 Years
ALL
No
Sponsors
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CVRx, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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George Bakris, MD
Role: STUDY_CHAIR
The University of Chicago Medicine
John Bisognano, MD
Role: STUDY_CHAIR
University of Rochester
Fred Weaver, MD
Role: STUDY_CHAIR
Keck School of Medicine of the University of Southern California
William Abraham, MD
Role: STUDY_CHAIR
Ohio State University
Locations
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Arizona Heart Rhythm Research Center
Phoenix, Arizona, United States
University of Southern California
Los Angeles, California, United States
George Washington University
Washington D.C., District of Columbia, United States
Florida Hospital
Orlando, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, United States
Michigan CardioVascular Institute
Saginaw, Michigan, United States
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Aspirus Wausau Hospital
Wausau, Wisconsin, United States
Countries
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Other Identifiers
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360039
Identifier Type: -
Identifier Source: org_study_id
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