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.
• 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.