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RECRUITING
NCT07399587
PHASE2/PHASE3

Optimizing HFrEF Patients Using BaroStim and CardioMems

Sponsor: Northwell Health

View on ClinicalTrials.gov

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

Interventions

DEVICE

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