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

CVRx Incorporated0 个研究点目标入组 70 人开始时间: 2015年9月22日最近更新: 2024年8月19日

适应症

试验速览

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•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.

•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.

发起方

CVRx Incorporated