Optimizing HFrEF Patients Using BaroStim and CardioMems

Part of paid clinical trials in Riverhead, New York.

Sponsor
Northwell Health
Study ID
NCT07399587
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Heart Failure NYHA Class III

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jan 17, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BaroStim
    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.

Primary Outcome Measure

Pulmonary Artery Diastolic Pressure [ Time Frame: During procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Peconic Bay Medical CenterRiverheadNew York11901
Shreya Srivastava, MD
[email protected]
516-881-7067
Maryyam Mian, MD
[email protected]
516-881-7067
John Kassotis, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Peconic Bay Medical Center· Riverhead, NY

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