NCT04583527已完成1 期
Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Preserved or Mid-Range Left Ventricular Ejection Fraction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
研究概览
简要总结
Patients with heart failure and preserved left ventricular ejection fraction (HFpEF, EF ≥ 50%) or mid-range left ventricular ejection fraction (HFmrEF, 40% < EF < 50%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
- •History of at least one hospitalization for treatment of heart failure within the past 12 months.
- •LVEF greater than 40% as measured by the study-specific transthoracic echocardiography.
- •Echocardiographic evidence of diastolic dysfunction documented by one or more of the following as measured by the study-specific transthoracic echocardiography protocol performed during screening:
- •LA diameter greater than 4 cm
- •LA volume index greater than 28 mL
- •Lateral e' less than 10 cm/s
- •Septal e' less than 8 cm/s
- •Lateral E/e' greater than 10
- •Septal E/e' greater than 15
- •Elevated left atrial pressure WITH a gradient compared to right atrial pressure (RAP) documented by:
- •(1) end-expiratory PCWP at peak supine cycle ergometer exercise greater than or equa. to 25 mmHg AND (2) PCWP greater than RAP by greater than or equal to 5 mmHg, OR greater than or equal to 10 mmHg increase of end-expiratory PCWP at peak supine cycle ergometer exercise compared to resting PCWP AND PCWP greater than RAP by greater than or equal to 5 mmHg.
排除标准
- •Presence of advanced heart failure defined as one or more of the following:
- •ACC/AHA/ESC Stage D heart failure, non-ambulatory NYHA Class IV HF.
- •Cardiac index less than 2.0 L/min/m
- •Patient is on the cardiac transplant waiting list.
- •Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months.
- •Presence of moderate or worse valve disease, defined as one or more of the following:
- •Moderate or worse mitral valve regurgitation or moderate or worse mitral stenosis.
- •Moderate or worse tricuspid valve regurgitation.
- •Moderate or worse aortic valve disease defined as moderate or worse AS or AI.
- •. Presence of chronic pulmonary disease defined by one or more of the following:
- •Requirement for continuous home oxygen use.
- •Hospitalization within the past 12 months for treatment of pulmonary disease.
- •Significant chronic pulmonary disease defined as FEV1 less than 50%.
- •Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
- •6-minute walk distance less than 50 m or greater than 450 m performed during screening.
- •Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
- •Presence of moderate or worse right heart dysfunction OR RV dysfunction defined as TAPSE less than 14 mm or RVFAC less than or equal to 30%
- •Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
- •Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
- •SBP greater than 170 mmHg at screening.
- •Documented left ventricular end diastolic diameter greater than 6 cm.
结局指标
主要结局
The composite incidence of one or more of the following through the 1-month follow-up visit: major adverse cardiac, cerebrovascular and thromboembolic events.
时间窗: At one month
次要结局
未报告次要终点
研究者
研究点 (1)
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