NCT04502316

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

Real-World Experience -- Barostim™ Advancing the Level of Clinical Evidence (REBALANCE Registry) A Post-Market Registry With the Barostim™ System

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: CVRx, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Summary: The CVRx REBALANCE Registry includes patients who have been implanted with the Barostim System. Up to 5,000 patients will be enrolled. Data should be obtained from evaluations taken prior to implant, at implant, and every six months after device implant, up to the 36-month visit at which time each patient will be exited from the registry. Enrollment data are collected retrospectively after consent and Barostim implant; post-enrollment data are collected prospectively from standard of care follow-up.

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	Barostim™ System	Implantation of the Barostim™ System

Timeline

• Start date: 2020-06-26
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2020-08-06
• Last updated: 2026-02-10

Locations

46 sites across 1 country: United States

Regulatory

• FDA-regulated device study