Recruiting
Phase 2
Phase 3

CardioMems & BaroStim

Sponsor:

Northwell Health

Code:

NCT07399587

Conditions

Heart Failure NYHA Class III

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BaroStim

Study Details

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

Study ID

NCT07399587

Start date

Jan 17, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Pulmonary Artery Diastolic Pressure [ Time Frame: During procedure ]
  • 6 Minute Walk Test [ Time Frame: Through study completion, 1 year ]
  • Blood Pressure [ Time Frame: Through study completion, 1 year ]
  • NYHA Class of Heart Failure [ Time Frame: Through study completion, 1 year ]
  • NT-pro BNP Levels [ Time Frame: Through study completion, 1 year ]
  • LVEF [ Time Frame: Through study completion, 1 year ]
  • Medication Usage [ Time Frame: Through study completion, 1 year ]

Central Contacts and Locations

Central contacts

Shreya Srivastava, MD

516-881-7067ssrivastava3@northwell.edu

Maryyam Mian, MD

516-881-7067MMian12@northwell.edu

Locations

Peconic Bay Medical Center

Recruiting

Riverhead, New York, United States, 11901

Contacts

Shreya Srivastava, MD

516-881-7067ssrivastava3@northwell.edu

Maryyam Mian, MD

516-881-7067MMian12@northwell.edu

Principal Investigator:

John Kassotis, MD

More Information

Sponsor

Northwell Health

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • NYHA Class III heart failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-02-10.