Using BaroStim and CardioMems to improve care for NYHA Class III heart failure

Optimizing the Management of Patients With Heart Failure With Reduced Ejection Fraction Using BaroStim and CardioMems

This study will see if adding BaroStim after three months of CardioMems-guided medication optimization helps people with NYHA Class III heart failure and LVEF under 35%.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Northwell Health (other)
• Locations: 1 site (Riverhead, New York)
• Trial ID: NCT07399587 on ClinicalTrials.gov

What this trial studies

This is a single-arm, longitudinal study where each patient serves as their own control before BaroStim implantation. Patients who receive a CardioMems device will undergo three months of guideline-directed medication titration, then receive BaroStim per standard of care and be followed for one year. Follow-up visits will include BaroStim titration and repeated measurements of pulmonary artery diastolic pressure (PADP), 6-minute walk distance, vital signs, NT-proBNP, LVEF, and NYHA class. The protocol aims to use PADP (target ≤18–20 mmHg) from CardioMems as an objective guide to optimize BaroStim therapy and define clinically meaningful improvement as a 10% change in several functional or biomarker measures or any NYHA class improvement.

Who should consider this trial

Good fit: Adults 18–80 years old with NYHA Class III heart failure, LVEF <35%, who can tolerate guideline-directed medication titration and have undergone CardioMems and are candidates for BaroStim.

Not a fit: Patients who are ineligible for CardioMems or BaroStim, cannot tolerate GDMT titration, have advanced comorbid conditions, or are pregnant are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, combining PADP-guided management with BaroStim could lower pulmonary pressures, improve exercise capacity and heart failure biomarkers, and reduce symptoms and hospitalizations.

How similar studies have performed: CardioMems and BaroStim (BAT) have each shown clinical benefits in prior studies, but using PADP-guided management to optimize BaroStim is a novel combination that has not been widely tested.

Eligibility criteria

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

Where this trial is running

Riverhead, New York

• Peconic Bay Medical Center — Riverhead, New York, United States (RECRUITING)

Study contacts

• Principal investigator: John Kassotis, MD — Northwell Health
• Study coordinator: Shreya Srivastava, MD

Conditions: Heart Failure NYHA Class III, NYHA Class III heart failure