About this trial
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 criteria
Qualifiers
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%
Disqualifiers
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
Trial design
Treatments tested in this trial
- BaroStim
Treatment groups
Locations
1Sponsors and collaborators
Northwell Health
Lead sponsor