Improving Care for Adults with Heart Failure Using BaroStim and CardioMems Devices

What this Trial Is About

This research aims to optimize treatment for patients with Heart Failure NYHA Class III who have reduced ejection fraction LVEF less than 35%. It evaluates the use of BaroStim, a device implanted after CardioMems insertion, to monitor and manage pulmonary artery diastolic pressure and other heart function markers. The study is sponsored by Northwell Health and follows patients over an extended period to assess changes in heart health and function. Patients who qualify for both CardioMems and BaroStim devices will first receive the CardioMems implant and undergo 3 months of medication management and optimization. Following this, BaroStim will be implanted and titrated during office visits, with ongoing monitoring of pulmonary artery pressures, blood pressure, and exercise capacity. The goal is to maintain pulmonary artery diastolic pressure at 18-20 mm Hg or less. The study includes a 1-year follow-up after BaroStim insertion to track heart function and symptoms. Participants will attend regular in-office visits for device adjustment and measurements, including the 6-minute walk test, vital signs, and laboratory tests such as NT-pro BNP levels. Researchers will observe changes in heart failure classification, medication use, and hospitalizations over the study period. Continuous monitoring of pulmonary artery diastolic pressure via CardioMems will help assess the impact of BaroStim. The total participation time extends through at least one year following BaroStim implantation.

Optimizing HFrEF Patients Using BaroStim and CardioMems