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BAROSTIM NEO Hypertension Pivotal Trial
Sponsor: CVRx, Inc.
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).
Key Details
Gender
All
Age Range
21 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2013-04-12
Completion Date
2025-07-23
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (11)
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
Petosky, 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