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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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months post-implant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of serious adverse events related to the system or implant procedure
Secondary outcome measures
Change NYHA Classification
Change in LVEF
Change in NT-proBNP
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Who is running the clinical trial?
CVRx, Inc.Lead Sponsor
20 Previous Clinical Trials
3,531 Total Patients Enrolled
11 Trials studying Heart Failure
2,252 Patients Enrolled for Heart Failure
Thomas DeeringStudy ChairPiedmont Heart Institute
Bradley KnightStudy ChairNorthwestern Medicine
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