Actively Recruiting
Optimizing HFrEF Patients Using BaroStim and CardioMems
Led by Northwell Health · Updated on 2026-02-10
15
Participants Needed
1
Research Sites
258 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing HFrEF Patients Using BaroStim and CardioMems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent given
- Willingness to comply with all study procedures and be available for the study duration
- Male or female aged 18 to 80 years
- Diagnosed with NYHA Class III heart failure with left ventricular ejection fraction less than 35%
- Able to tolerate oral medications for guideline-directed medical therapy
- Have had CardioMems and BaroStim devices inserted according to standard care
- Women of childbearing potential agree to use highly effective contraception during and after the study
You will not qualify if you...
- Not eligible for CardioMems or BaroStim devices
- NT-proBNP level greater than 1600 mg/dL
- Indicated for CRT-D device due to left bundle branch block
- Initial 6-minute walk test distance less than 140 meters
- Have a left ventricular assist device (LVAD)
- History of carotid vascular procedures such as carotid endarterectomy
- Pregnant or breastfeeding
- Allergic reactions to components of BaroStim, CardioMems, or heart failure medications
- Febrile illness within 30 days before enrollment
- Treatment with another investigational drug or intervention within one year
- Current smoker or tobacco use within one year
- Enrolled in any other CVRx funded study
- Classified as a vulnerable individual as defined by the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peconic Bay Medical Center
Riverhead, New York, United States, 11901
Actively Recruiting
Research Team
S
Shreya Srivastava, MD
CONTACT
M
Maryyam Mian, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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