BAROSTIM THERAPY ™ in Heart Failure With Preserved Ejection Fraction: A Post-Market Registry With the CE-Marked BAROSTIM NEO™ System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CVRx, Inc.
- 入组人数
- 11
- 试验地点
- 26
- 主要终点
- Changes in Office Cuff Systolic Blood Pressure
研究概览
简要总结
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).
详细描述
Summary:
The CVRx BAROSTIM THERAPY in Heart Failure with Preserved Ejection Fraction (HFpEF) Registry will be performed with subjects who have been recently implanted with the BAROSTIM NEO System in accordance with CE-Mark approved criteria for resistant hypertension and have evidence of HFpEF per the registry enrollment criteria. Subjects must be enrolled within 30 days from implant but prior to therapy activation. Up to 70 subjects will be enrolled at up to 10 sites. Data should be obtained from standard of care measurements taken prior to implant, at enrollment/baseline, and at 3 and 6 months after the device was implanted, at which time each subject will be exited from the registry.
Eligibility Criteria:
The CE-Mark approved indications and contraindications for the BAROSTIM NEO system in the treatment of resistant hypertension include:
- Indications
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Changes in Office Cuff Systolic Blood Pressure
时间窗: Pre-implant baseline to 6 months post-implant
Office cuff blood pressure measurement to be obtained from a time point prior to implant and as close to the implant procedure as possible (baseline), and at 3 and 6 months post-implant.
次要结局
- Changes in NT-proBNP(Pre-implant baseline, 6 months post-implant)
- Change in New York Heart Association Functional Classification(Pre-implant baseline to 6 months post-implant)
- Changes in Left Ventricular Mass Index(Pre-implant baseline to 6 months post-implant)
- Evaluate health care utilization over follow-up, such as heart failure hospitalizations(Pre-implant baseline to 6 months post-implant)
- Changes in LA volume index(Pre-implant baseline to 6 months post-implant)
- Changes in E/E' ratio(Pre-implant baseline to 6 months post-implant)