NCT07399587RecruitingPhase 2/3
Optimizing HFrEF Patients Using BaroStim and CardioMems
Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems
Source: ClinicalTrials.gov · Last updated 10 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- Jan 2025
- Primary completion date
- Dec 2028
- Lead sponsor
- Northwell Health
- Diseases
- Heart failure
- NCT number
- NCT07399587
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 15
- From Jan 2025 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with another investigational drug or other intervention within 1 year
Other illness
- 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
Lab values
- NT-proBNP \>1600 mg/dL
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peconic Bay Medical Center Coordinator of this site? Confirm its status | Riverhead | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.