Optimizing HFrEF Patients Using BaroStim and CardioMems

NCT07399587 | Recruiting Phase 2

• 1 other identifier: 24-0583
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Heart Failure NYHA Class III

Keywords

NYHA Class III heart failure

Outcome Measures

Primary Outcomes (7)

• Pulmonary Artery Diastolic Pressure

  Pulmonary Artery Diastolic Pressure as Measured by CardioMems Device

  During procedure

• 6 Minute Walk Test

  Distance covered in 6 minute walk test

  Through study completion, 1 year

• Blood Pressure

  Systolic and diastolic blood pressure at repeated clinic visits

  Through study completion, 1 year

• NYHA Class of Heart Failure

  Any change or improvement of NYHA Class of Heart Failure

  Through study completion, 1 year

• NT-pro BNP Levels

  Any change or improvement of NT-pro BNP levels

  Through study completion, 1 year

• LVEF

  Any change or improvement in LVEF

  Through study completion, 1 year

• Medication Usage

  Any change or improvement in medication usage

  Through study completion, 1 year

Secondary Outcomes (1)

• Incidence of Hospitalizations

  Through study completion, 1 year

Study Arms (1)

BaroStim

EXPERIMENTAL

The intervention is insertion and titration of BaroStim. This is for patients with NYHA Class III heart failure who are candidates for CardioMems insertion (or have already received CardioMems in the past 3 months) and subsequent BaroStim insertion.

Device: BaroStim

Interventions

BaroStim DEVICE

BaroStim NEO or BaroStim NEO2 will be used in this study. The device consists of a Carotid sinus lead 2 mm in thickness and an implantable pulse generator. The study intervention is monitoring of CardioMems reading while titrating the BaroStim device.

BaroStim

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Individuals ineligible for either CardioMems or BaroStim devices.
• NT-proBNP \>1600 mg/dL
• Indicated for CRT-D device (left bundle branch block)
• Initial 6-minute walk test distance less than 140 m
• Left ventricular assist device (LVAD)
• History of carotid vascular procedure (carotid endarterectomy)
• Pregnancy or lactation
• 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
• Treatment with another investigational drug or other intervention within 1 year
• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Peconic Bay Medical Center

Riverhead, New York, 11901, United States

RECRUITING

Study Officials

• John Kassotis, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shreya Srivastava, MD

CONTACT

516-881-7067; ssrivastava3@northwell.edu

Maryyam Mian, MD

CONTACT

516-881-7067; MMian12@northwell.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: February 10, 2026
• Study Start: January 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (1)