BAROSTIM THERAPY ™ in Heart Failure With Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
The purpose of this registry (NCT02876042) is to evaluate the effect of BAROSTIM THERAPY with the BAROSTIM NEO system in the commercial setting in subjects recently implanted under the CE-Marked indication for resistant hypertension that also have evidence of heart failure with preserved ejection fraction (HFpEF).
• Sign an Ethics Committee (EC) approved informed consent form for the registry.
• Implanted with the BAROSTIM NEO system in accordance with CE-Mark approved indications and contraindications for resistant hypertension within 30 days prior to enrollment.
• BAROSTIM THERAPY not yet chronically activated.
• Pre-implant echocardiogram with left ventricular ejection fraction ≥ 50% within 30 days prior to implant.
• On stable, maximally-tolerated, guideline-directed cardiovascular medications for at least 30 days prior to enrollment.
• 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 30 days 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 30 days prior to enrollment