BAROSTIM NEO Hypertension Pivotal Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CVRx, Inc.
- Enrollment
- 10
- Locations
- 23
- Primary Endpoint
- To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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.
Exclusion Criteria
- •Treating physician decision that the subject should not continue with therapy.
Arms & Interventions
BAROSTIM NEO System
Subjects implanted with the BAROSTIM NEO System.
Intervention: BAROSTIM NEO System and Medical Management (Device)
Outcomes
Primary Outcomes
To assess long-term adverse events in subjects implanted with the BAROSTIM NEO System.
Time Frame: 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 Outcomes
No secondary outcomes reported