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Optimizing HFrEF Patients Using BaroStim and CardioMems
Sponsor: Northwell Health
Summary
The goal of this study is to utilize CardioMems (measurement of pulmonary artery diastolic pressure) to assess BaroStim. At the time of CardioMems insertion, patients will be screened for candidacy to receive a BaroStim device. Patients will be followed for 3 months after the CardioMems insertion before undergoing insertion of a Barostim. Patients who have undergone a CardioMems, will be eligible for enrollment after 3 months of medication management and optimization. Patients will be followed for 1 year after insertion of Barostim.
Official title: Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2025-01-17
Completion Date
2029-12-31
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
BaroStim
BaroStim NEO or BaroStim NEO2 will be used in this study. The device consists of a Carotid sinus lead 2 mm in thickness and an implantable pulse generator. The study intervention is monitoring of CardioMems reading while titrating the BaroStim device.
Locations (1)
Peconic Bay Medical Center
Riverhead, New York, United States