Barostim Therapy™ in Heart Failure with Preserved Ejection Fraction: A Data Collection Registry with the CE-Marked Barostim neo™ System

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

g inclusion criteria:
1. Implanted with the Barostim Neo system in accordance with CE-Mark approved criteria for resistant hypertension, within 14 days prior to enrollment.
2. No ongoing adverse events related to the Barostim Neo implant procedure.
3. Barostim Therapy not yet chronically activated.
4. Pre-implant echocardiogram with left ventricular ejection fraction = 50% within 1 month prior to enrollment.
5. On stable, maximally-tolerated, guideline-directed hypertension/heart failure medications for at least 30 days prior to enrollment.
6. Objective evidence of heart failure according to the following criteria:
• Hospitalization for heart failure within 12 months prior to enrollment OR
• Echocardiographic evidence of diastolic dysfunction (LA Volume Index >34 ml/m2 OR E/e >13) within 1 month prior to enrollment OR
• NTproBNP > 220 pg/mL or BNP > 80 pg/mL (in atrial fibrillation, NTproBNP > 600 pg/mL or BNP > 200 pg/mL) within 1 month prior to enrollment
7. Signed a CVRx-approved informed consent form for the registry.

Exclusion Criteria

1. Heart failure secondary to a reversible or treatable condition such as, cardiac structural valvular disease, acute myocarditis and pericardial constriction.
2. Heart failure secondary to right ventricular failure or right ventricular myocardial infarction.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To describe change in office cuff systolic blood pressure at 6 months compared to pre-implant baseline.

Secondary Outcome Measures

Name	Time	Method
To describe changes in the following measures at 6 months compared to pre-implant baseline:<br>• Left ventricular mass index<br>• LA volume index<br>• E/E’ ratio<br>• Other echocardiographic measures<br>To describe changes in the following measures at 6 months compared to pre-activation baseline:<br>• NYHA Class<br>• NT-pro-BNP, as routinely collected as standard of care<br>• Other biomarkers of end organ damage routinely collected as standard of care (e.g., eGFR, Troponin T, etc.)<br>