Last reviewed · How we verify
Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System
The purpose of this registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients with heart failure with reduced ejection fraction (HFrEF) that were recently implanted with the Barostim System.
Details
| Lead sponsor | CVRx, Inc. |
|---|---|
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 5000 |
| Start date | 2020-06-26 |
| Completion | 2028-06 |
Conditions
- Heart Failure
Interventions
- Barostim™ System
Primary outcomes
- The primary objective of this post-market registry is to develop valid scientific evidence of the safety and benefit of Barostim Therapy in the commercial setting in patients that were recently implanted with the Barostim System. — 36 months post-implant
Countries
United States