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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.
This is a longitudinal, single arm study in which patients will serve as their own controls prior to study intervention (BaroStim insertion). All patients eligible for both CardioMems and BaroStim devices will undergo insertion per standard of care, regardless of participation in this study. After placement of CardioMems, patients will undergo 3 months of medication management and titration. After 3 months of medication titration, patients will undergo BaroStim insertion. This sequential placement of devices along with the 3 month medication titration period is standard of care and will occur prior to enrollment in the study. Subsequently, patients will be seen for in-office visits for titration of BaroStim along with measurement of pulmonary artery diastolic pressure, 6MWT, and vital signs. The goal will be to achieve a pulmonary artery diastolic pressure (PADP) of 18-20 mm Hg or less. Patients will be followed for up to 1-year post-insertion.
The goal of this study is to utilize the pulmonary artery diastolic pressure (obtained from CardioMems) as an objective method to assess BAT. A 10% improvement in 6MWT, blood pressure, PADP, NT pro-BNP, or LVEF, or any improvement in NYHA class is deemed clinically significant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BaroStim | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pulmonary Artery Diastolic Pressure | Pulmonary Artery Diastolic Pressure as Measured by CardioMems Device | During procedure |
| 6 Minute Walk Test | Distance covered in 6 minute walk test | Through study completion, 1 year |
| Blood Pressure | Systolic and diastolic blood pressure at repeated clinic visits | Through study completion, 1 year |
| NYHA Class of Heart Failure | Any change or improvement of NYHA Class of Heart Failure | Through study completion, 1 year |
| NT-pro BNP Levels | Any change or improvement of NT-pro BNP levels | Through study completion, 1 year |
| LVEF | Any change or improvement in LVEF | Through study completion, 1 year |
| Medication Usage | Any change or improvement in medication usage | Through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Hospitalizations | Incidence of hospitalizations for acute decompensated heart failure during study period. | Through study completion, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shreya Srivastava, MD | Contact | 516-881-7067 | ssrivastava3@northwell.edu | |
| Maryyam Mian, MD | Contact | 516-881-7067 | MMian12@northwell.edu |
| Name | Affiliation | Role |
|---|---|---|
| John Kassotis, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peconic Bay Medical Center | Recruiting | Riverhead | New York | 11901 | United States |
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