Heart Failure NYHA Class IIIPhase 2/3NCT07399587
Optimizing HFrEF Patients Using BaroStim and CardioMems
A Phase 2/3 study testing BaroStim in people with Heart Failure NYHA Class III, run by Northwell Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Failure NYHA Class III
- What is being tested?
- BaroStim
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2025to 31 Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Peconic Bay Medical Center
Riverhead, New York, 11901
Shreya Srivastava, MD, 516-881-7067, ssrivastava3@northwell.edu
Maryyam Mian, MD, 516-881-7067, MMian12@northwell.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure NYHA Class III
- Being tested
- BaroStim
- Keywords
- NYHA Class III heart failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaroStimDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BaroStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Artery Diastolic Pressure
Pulmonary Artery Diastolic Pressure as Measured by CardioMems Device
Measured: During procedure
6 Minute Walk Test
Distance covered in 6 minute walk test
Measured: Through study completion, 1 year
Blood Pressure
Systolic and diastolic blood pressure at repeated clinic visits
Measured: Through study completion, 1 year
NYHA Class of Heart Failure
Any change or improvement of NYHA Class of Heart Failure
Measured: Through study completion, 1 year
NT-pro BNP Levels
Any change or improvement of NT-pro BNP levels
Measured: Through study completion, 1 year
LVEF
Any change or improvement in LVEF
Measured: Through study completion, 1 year
Medication Usage
Any change or improvement in medication usage
Measured: Through study completion, 1 year
Secondary outcomes (1)
Incidence of Hospitalizations
Incidence of hospitalizations for acute decompensated heart failure during study period.
Measured: Through study completion, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start17 Jan 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure NYHA Class IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Kassotis, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399587
- Sponsor's protocol ID
- 24-0583
- Status last verified
- Feb 2026
- First submitted
- 22 Dec 2025
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems
- ClinicalTrials.gov ID
- NCT07399587
- Acronym / sponsor ID
- 24-0583
- Conditions
- Heart Failure NYHA Class III
- Keywords
- NYHA Class III heart failure
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 17 Jan 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BaroStim | Experimental | Device: BaroStimThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaroStimBaroStim 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. | Device | BaroStim |
Primary outcome
Pulmonary Artery Diastolic Pressure
Time frame: During procedure
Pulmonary Artery Diastolic Pressure as Measured by CardioMems Device
6 Minute Walk Test
Time frame: Through study completion, 1 year
Distance covered in 6 minute walk test
Blood Pressure
Time frame: Through study completion, 1 year
Systolic and diastolic blood pressure at repeated clinic visits
NYHA Class of Heart Failure
Time frame: Through study completion, 1 year
Any change or improvement of NYHA Class of Heart Failure
NT-pro BNP Levels
Time frame: Through study completion, 1 year
Any change or improvement of NT-pro BNP levels
LVEF
Time frame: Through study completion, 1 year
Any change or improvement in LVEF
Medication Usage
Time frame: Through study completion, 1 year
Any change or improvement in medication usage
1 secondary outcome
Incidence of Hospitalizations
Time frame: Through study completion, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
Related trials for Heart Failure NYHA Class III
Recruiting
Barostim-Enabled NEurohormonal Intervention For Improving Treatment of Heart Failure
Heart Failure, Heart Failure NYHA Class II
Recruiting
PrEcision Pacing in HFpEF: the PEP-HFpEF Trial
Heart Failure and Preserved Ejection Fraction, Heart Failure New York Heart Association Class III
Recruiting
NORM-HF Pivotal Study
Heart Failure, NYHA Class III Heart Failure
Not yet recruiting
Inspiratory Muscle Training in Hospitalized Patients With Heart Failure Awaiting Advanced Therapies
Heart Failure, Heart Failure New York Heart Association Class III
Not yet recruitingObservational study
Dietary Tracking in Heart Failure
Heart Failure, NYHA Class II Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Kassotis, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BaroStim in people with Heart Failure NYHA Class III, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shreya Srivastava, MD (516-881-7067, ssrivastava3@northwell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Artery Diastolic Pressure (time frame: During procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.