BaroStim and CardioMems for Heart Failure With Reduced Ejection Fraction
Tests the BaroStim device in adults with heart failure, using CardioMems pressure readings.
Plain-language title generated from the registry record
Registry title: Optimizing HFrEF Patients Using BaroStim and CardioMems
Key facts
- Where
- Riverhead, United StatesSee the site
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07399587, who can take part
Where in United States
- Peconic Bay Medical CenterRiverhead, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Northwell Health
- Trial code
- NCT07399587
- Record updated
- 10 February 2026
- Original description
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.Read full original descriptionShow less
Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems
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.
Inclusion: Provision of signed and dated informed consent form; Stated willingness to comply with all study procedures and availability for the duration of the study; Male or female, ages 18-80 years; Diagnosed with NYHA Class III Heart Failure with LVEF<35%; Able to tolerate oral medications for guideline directed medical therapy titration period; Have undergone insertion of CardioMems and BaroStim devices per standard of care; It is a standard of care to recommend that females of reproductive potential use highly effective contraception, because of the teratogenic potential of many medications used to treat HFrEF. In addition, withdrawal of GDMT during pregnancy may reverse the positive remodeling and lead to life threatening worsening of heart failure. Women of child-bearing age need to agree to use such a method during study participation and indefinitely after the end of the study.
Exclusion: Treatment with another investigational drug or other intervention within 1 year; History of carotid vascular procedure (carotid endarterectomy); Known allergic reactions to components of the BaroStim or CardioMems insertion or guideline directed medical therapy for heart failure; Febrile illness within 30 days of study enrollment; NT-proBNP >1600 mg/dL; Individuals ineligible for either CardioMems or BaroStim devices; Indicated for CRT-D device (left bundle branch block); Initial 6-minute walk test distance less than 140 m; Left ventricular assist device (LVAD); Pregnancy or lactation; Current smoker or tobacco use within 1 year; Enrolled in any other CVRx funded study, including investigator-initiated research, registries, or other pre- or post-market studies; Vulnerable individuals as outlined below.