Clinical Trial

Real-World Experience - Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry)

Terminated
View on ClinicalTrials.gov →
Why the trial stopped
Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes.
Summary
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.
Protocol Amendment History 5 changes
critical Trial terminated 2026-07-31
critical Trial terminated: Participant follow-up through 12 months post-Barostim Implant sufficient for data collection and analysis purposes. 2026-07-31
notable Enrollment reduced: 5000 -> 435 participants 2026-07-31
notable Primary completion moved earlier: 2028-06 -> 2026-05-14 2026-07-31
minor Completion moved earlier: 2028-06 -> 2026-06-30 2026-07-31
Trial Details
NCT Number NCT04502316
Lead Sponsor CVRx, Inc.
Conditions Heart Failure
Enrollment 435 participants
Start Date 2020-06-26
Primary Completion 2026-05-14 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-30