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