BAROSTIM THERAPY™ In Heart Failure With Preserved Ejection Fraction

Other illness

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

• 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