RecruitingPhase 2Phase 3NCT07399587

Optimizing HFrEF Patients Using BaroStim and CardioMems

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

Sponsor

Northwell Health

Enrollment

15 participants

Start Date

Jan 17, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure NYHA Class III

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria7

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.

Exclusion Criteria13

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

Interventions

DEVICEBaroStim

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.