ACTRN12620001213932尚未招募未知
Evaluation of the Safety and Effectiveness of a Percutaneously Created Interatrial Shunt on 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
- 未知
- 状态
- 尚未招募
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •Candidates for the study must meet all of the following inclusion criteria at
- •1. Documented history of NYHA Class II, Class III or ambulatory Class IV at the screening visit.
- •2. History of at least one hospitalization for treatment of heart failure within the past 12 months.
- •3. LVEF greater than or equal to 40% as measured by the study-specific transthoracic echocardiography.
- •4. 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
- •5. 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
- •Candidates for the study must be free of all of the following exclusion
- •criteria at screening:
- •1. 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/m2.
- •- Patient is on the cardiac transplant waiting list.
- •- Inotropic infusion (continuous or intermittent) for EF less than 40% within the past 6 months.
- •2. 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.
- •3. . 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%.
- •4. Documented as currently requiring dialysis or estimated GFR less than 25ml/min/1.73m2
- •5. 6-minute walk distance less than 50 m or greater than 450 m performed during screening.
- •6. Documented atrial fibrillation with ventricular rate greater than 100 BPM at screening.
- •7. 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%
- •8. Presence of pulmonary hypertension with PASP greater than or equal to 70 mmHg OR PVR greater than 4 Wood units.
- •9. Presence of anatomic anomaly that precludes creation of interatrial shunt (including patent foramen ovale, atrial septal defect, target septal thickness greater than 3 mm)
- •10. SBP greater than 170 mmHg at screening.
- •11. Documented left ventricular end diastolic diameter greater than 6 cm.
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