RecruitingPhase 2Phase 3NCT07399587

Optimizing HFrEF Patients Using BaroStim and CardioMems

Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems

Sponsor

Northwell Health

Enrollment

15 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure NYHA Class III

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two implanted devices for people with severe heart failure: the BaroStim device (which stimulates a blood pressure sensor in the neck to reduce the heart's workload) and the CardioMEMS sensor (which monitors pressure inside the heart's main pumping chamber wirelessly from home). Researchers want to see if using both devices together improves symptoms and reduces hospitalizations. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with NYHA Class III heart failure (significant symptoms with moderate exertion) with a low heart pumping function (LVEF under 35%) - You have already had both the BaroStim and CardioMEMS devices implanted - You are able to take guideline-directed heart failure medications **You may NOT be eligible if...** - You are not a candidate for one or both devices - You have very severe kidney disease or other conditions that limit medication options - You are pregnant - You are unable to comply with the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBaroStim

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.