BAROSTIM NEO Hypertension Pivotal Trial
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
Phase
N/AInclusion and Exclusion 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.
- Treating physician decision that the subject should not continue with therapy.
Sites
-
California
- University of Southern California, Los Angeles, California, 90033
-
Nevada
- University Medical Center of Southern Nevada, Las Vegas, Nevada, 89102
-
Arizona
- Arizona Heart Rhythm Research Center, Phoenix, Arizona, 85006
-
Oklahoma
- Oklahoma Heart hospital, Oklahoma City, Oklahoma, 73120
-
Louisiana
- Cardiovascular Institute of the South, Houma, Louisiana, 70361
-
Wisconsin
- Aspirus Wausau Hospital, Wausau, Wisconsin, 54401
-
Michigan
- Cardiac and Vascular Research Center of Northern Michigan, Petosky, Michigan, 49770
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