Health TrialsbyHealthPanel

Optimizing HFrEF Patients Using BaroStim and CardioMems

ConditionHeart Failure NYHA Class III
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • BaroStim

    Device

    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.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: BaroStimExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pulmonary Artery Diastolic Pressure

Pulmonary Artery Diastolic Pressure as Measured by CardioMems Device

Time frame
During procedure
2

6 Minute Walk Test

Distance covered in 6 minute walk test

Time frame
Through study completion, 1 year
3

Blood Pressure

Systolic and diastolic blood pressure at repeated clinic visits

Time frame
Through study completion, 1 year
4

NYHA Class of Heart Failure

Any change or improvement of NYHA Class of Heart Failure

Time frame
Through study completion, 1 year

Secondary outcomes

1

Incidence of Hospitalizations

Incidence of hospitalizations for acute decompensated heart failure during study period.

Time frame
Through study completion, 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
Apply now