Optimizing HFrEF Patients Using BaroStim and CardioMems

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure NYHA Class III
• Intervention / Treatment: Device: BaroStim

Detailed Description

This is a longitudinal, single arm study in which patients will serve as their own controls prior to study intervention (BaroStim insertion). All patients eligible for both CardioMems and BaroStim devices will undergo insertion per standard of care, regardless of participation in this study. After placement of CardioMems, patients will undergo 3 months of medication management and titration. After 3 months of medication titration, patients will undergo BaroStim insertion. This sequential placement of devices along with the 3 month medication titration period is standard of care and will occur prior to enrollment in the study. Subsequently, patients will be seen for in-office visits for titration of BaroStim along with measurement of pulmonary artery diastolic pressure, 6MWT, and vital signs. The goal will be to achieve a pulmonary artery diastolic pressure (PADP) of 18-20 mm Hg or less. Patients will be followed for up to 1-year post-insertion.

The goal of this study is to utilize the pulmonary artery diastolic pressure (obtained from CardioMems) as an objective method to assess BAT. A 10% improvement in 6MWT, blood pressure, PADP, NT pro-BNP, or LVEF, or any improvement in NYHA class is deemed clinically significant.

• Study Type: Interventional
• Enrollment (Estimated): 15
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Shreya Srivastava, MD; Phone Number: 516-881-7067; Email: ssrivastava3@northwell.edu
• Study Contact Backup: Name: Maryyam Mian, MD; Phone Number: 516-881-7067; Email: MMian12@northwell.edu

Study Locations

• United States
  • New York
    • Riverhead, New York, United States, 11901
      • Recruiting
      • Peconic Bay Medical Center
      • Contact: Shreya Srivastava, MD; Phone Number: 516-881-7067; Email: ssrivastava3@northwell.edu
      • Contact: Maryyam Mian, MD; Phone Number: 516-881-7067; Email: MMian12@northwell.edu
      • Principal Investigator: John Kassotis, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, ages 18-80 years
4. Diagnosed with NYHA Class III Heart Failure with LVEF<35%
5. Able to tolerate oral medications for guideline directed medical therapy titration period
6. Have undergone insertion of CardioMems and BaroStim devices per standard of care.
7. 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 Criteria:

1. Individuals ineligible for either CardioMems or BaroStim devices.
2. NT-proBNP >1600 mg/dL
3. Indicated for CRT-D device (left bundle branch block)
4. Initial 6-minute walk test distance less than 140 m
5. Left ventricular assist device (LVAD)
6. History of carotid vascular procedure (carotid endarterectomy)
7. Pregnancy or lactation
8. Known allergic reactions to components of the BaroStim or CardioMems insertion or guideline directed medical therapy for heart failure
9. Febrile illness within 30 days of study enrollment
10. Treatment with another investigational drug or other intervention within 1 year
11. Current smoker or tobacco use within 1 year
12. Enrolled in any other CVRx funded study, including investigator-initiated research, registries, or other pre- or post-market studies.
13. Vulnerable individuals as outlined below

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BaroStim; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Hospitalizations	Incidence of hospitalizations for acute decompensated heart failure during study period.	Through study completion, 1 year

Collaborators and Investigators

• Sponsor: Northwell Health
• Investigators: Principal Investigator: John Kassotis, MD, Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 10, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: NYHA Class III heart failure
• Other Study ID Numbers: 24-0583

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No