BAROSTIM NEO Hypertension Pivotal Trial

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Conditions studied: Uncontrolled Hypertension

In brief

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 facts

Study ID

NCT01679132

Run by

CVRx, Inc.

People needed

10

Starts

2013-04-12

Expected to finish

2026-03-01

Last updated by the study team

2025-07-15

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Treating physician decision that the subject should not continue with therapy.

Where it is running

• 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

Full record on ClinicalTrials.gov

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