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.
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.
Study Type
OBSERVATIONAL
Enrollment
5,000
Implantation of the Barostim™ System
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.
Time frame: 36 months post-implant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Grandview Medical Center
Birmingham, Alabama, United States
Chan Heart Rhythm Institute
Mesa, Arizona, United States
Akil Loli Consulting LLC
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Cabrillo Cardiology Research Group
Oxnard, California, United States
COR Healthcare Medical Associates
Torrance, California, United States
Aurora Denver Cardiology Associates
Aurora, Colorado, United States
South Denver Cardiology Associates, P.C.
Littleton, Colorado, United States
Medstar Health Research Insitutute
Washington D.C., District of Columbia, United States
The George Washington University Medical Faculty Associates
Washington D.C., District of Columbia, United States
Orlando Cardiac & Vascular Specialists
Altamonte Springs, Florida, United States
...and 36 more locations