Optimizing HFrEF Patients Using BaroStim and CardioMems

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwell Health

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

15 Participants
are divided into 1 treatment group

Locations

1
Peconic Bay Medical Center11901, RiverheadNew York, United States

Sponsors and collaborators

Northwell Health

Lead sponsor