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BAROSTIM NEO Hypertension Pivotal Trial
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).
Details
| Lead sponsor | CVRx, Inc. |
|---|---|
| Phase | NA |
| Status | SUSPENDED |
| Enrolment | 10 |
| Start date | 2013-04-12 |
| Completion | 2026-03 |
Conditions
- Uncontrolled Hypertension
Interventions
- BAROSTIM NEO System and Medical Management
Primary outcomes
- 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.
Countries
United States