Study of the Barostim System for Heart Failure Treatment

Unknown Not Applicable NCT04600791

Study Description

This clinical investigation aims to develop scientific evidence for the safety and effectiveness of the Barostim System, delivered by the BATwire Implant Kit, in heart failure patients. Patients who remain symptomatic despite medical therapy, have NYHA Class III/II, left ventricular ejection fraction ≤35%, and NT-proBNP <1600 pg/ml may be enrolled. This prospective study will include up to 400 subjects and will evaluate the implant experience, safety, and effectiveness of the BATwire kit. After implantation and activation, follow-up visits will occur at various intervals for up to 12 months.

Study Details

Registry ID:
NCT04600791
Conditions:
Heart Failure
Phase:
Not Applicable
Target Enrollment:
93 participants
Start Date:
Age Range:
21–80 years
Healthy Volunteers:
No

Study Locations (14 sites)

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