Optimizing Heart Failure Treatment with BaroStim and CardioMems

This study is looking at how well a device called BaroStim works for people with a type of heart failure called NYHA Class III Heart Failure. BaroStim is a small device implanted under the skin that helps regulate blood pressure. Researchers will use readings from another implanted device called CardioMems, which measures pressure in your lungs (pulmonary artery diastolic pressure), to help adjust the BaroStim device. The goal is to see if adjusting BaroStim based on these readings can improve your heart health. You might be able to join if you are 18-80 years old, have NYHA Class III Heart Failure with a weakened heart (LVEF<35%), and can take heart medications. The study will consider the treatment successful if there's an improvement in your walking ability (6 Minute Walk Test), blood pressure, or heart failure symptoms. The current status of this study is unclear.

Study design
This is a single-arm study, meaning all participants will receive the BaroStim intervention. It plans to enroll 15 participants.
What's involved
You would first have a CardioMems device implanted and receive 3 months of medication management. After that, a BaroStim device would be implanted, and you would have in-office visits for BaroStim adjustments and measurements for up to 1 year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 1 year after the BaroStim device is inserted.

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NCT07399587

Optimizing HFrEF Patients Using BaroStim and CardioMems

Recruiting
PHASE2Ages 18–80InterventionalTreatment
Northwell Health
~15 participants
Updated 2026-02-10 on ClinicalTrials.gov
What's tested:BaroStim

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pulmonary Artery Diastolic Pressure
Measured over During procedure
+6 more outcomes measured
Heart Failure NYHA Class III

NCT07399587

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Peconic Bay Medical Center

    Riverhead, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • John Kassotis, MD · PRINCIPAL_INVESTIGATOR · Northwell Health

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  • Pulmonary Artery Diastolic PressureDuring procedure

    Pulmonary Artery Diastolic Pressure as Measured by CardioMems Device

  • 6 Minute Walk TestThrough study completion, 1 year

    Distance covered in 6 minute walk test

  • Blood PressureThrough study completion, 1 year

    Systolic and diastolic blood pressure at repeated clinic visits

  • NYHA Class of Heart FailureThrough study completion, 1 year

    Any change or improvement of NYHA Class of Heart Failure

  • NT-pro BNP LevelsThrough study completion, 1 year

    Any change or improvement of NT-pro BNP levels

  • LVEFThrough study completion, 1 year

    Any change or improvement in LVEF

  • Medication UsageThrough study completion, 1 year

    Any change or improvement in medication usage