BAROSTIM NEO Hypertension Pivotal Trial
- Conditions
- Uncontrolled Hypertension
- Registration Number
- NCT01679132
- Lead Sponsor
- CVRx, Inc.
- 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
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 10
- 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.
- Treating physician decision that the subject should not continue with therapy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System. 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (11)
Arizona Heart Rhythm Research Center
🇺🇸Phoenix, Arizona, United States
University of Southern California
🇺🇸Los Angeles, California, United States
George Washington University
🇺🇸Washington, 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
Scroll for more (1 remaining)Arizona Heart Rhythm Research Center🇺🇸Phoenix, Arizona, United States