BaroStim for Heart Failure

Overseen By Shreya Srivastava, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Northwell Health

Disqualifiers: Pregnancy, Smoking, LVAD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

John Kassotis, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for heart failure patients who have had a CardioMems device inserted and undergone 3 months of medication management. Ideal candidates are those now considered for BaroStim therapy, which aims to optimize heart function.

Inclusion Criteria

I can take pills for my treatment.

Provision of signed and dated informed consent form

I am willing and able to follow all study requirements.

Exclusion Criteria

NT-proBNP >1600 mg/dL

Indicated for CRT-D device (left bundle branch block)

Left ventricular assist device (LVAD)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

At the time of CardioMems insertion

Medication Management

Patients undergo 3 months of medication management and titration after CardioMems insertion

3 months

Regular in-office visits for medication titration

BaroStim Insertion and Titration

Insertion and titration of BaroStim device, with monitoring of pulmonary artery diastolic pressure, 6MWT, and vital signs

1 year

In-office visits for titration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after BaroStim insertion

1 year

Regular clinic visits for monitoring

What Are the Treatments Tested in This Trial?

Interventions

• BaroStim

Trial Overview

The study tests the effectiveness of BaroStim in managing Heart Failure (HFrEF) by monitoring changes with CardioMems, which measures lung artery pressure. Patients will be observed for one year after receiving the BaroStim device.

How Is the Trial Designed?

Group I: BaroStim Experimental Treatment 1 Intervention

The intervention is insertion and titration of BaroStim. This is for patients with NYHA Class III heart failure who are candidates for CardioMems insertion (or have already received CardioMems in the past 3 months) and subsequent BaroStim insertion.

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+