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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Optimizing HFrEF Patients Using BaroStim and CardioMems
At a glance
Conditions
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.
Study leadership
- John Kassotis, MD · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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