NCT05403372进行中（未招募）不适用
Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
研究概览
简要总结
This is a prospective, single arm feasibility study to establish safety and performance of the PAS-C System in subjects with heart failure and elevated left atrial pressure.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented chronic, symptomatic heart failure and NYHA Class II, Class III or ambulatory Class IV at the time of screening visit and receiving guideline directed medical therapy.
- •At least one hospitalization or emergency department visit with heart failure as the primary or secondary diagnosis or intravenous diuretic treatment for heart failure or documentation of elevated BNP.
- •LVEF ≥ 40%.
- •Echocardiographic evidence of diastolic dysfunction during the baseline echocardiography:
- •Per baseline exercise right heart catheterization, site measured elevated left atrial pressure with a gradient compared to right atrial pressure.
排除标准
- •Stroke or thromboembolic event in the past 6 months.
- •Severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 2.0 L/min/m2, LVEDD > 6 cm, or received inotropic therapy for LVEF less than 40% within 6 months prior to enrollment.
- •Any of the following within 3 months prior to enrollment: myocardial infarction, percutaneous cardiac intervention, CABG, cardiac resynchronization therapy, AICD, or indicated for coronary revascularization at the time of enrollment.
- •More than moderate valve disease (mitral, tricuspid, aortic) at the time of enrollment.
- •Chronic pulmonary disease requiring continuous home oxygen or hospitalization within prior 12 months for pulmonary disease.
- •6-minute Walk Test distance less than 100 m or greater than 450 m performed during baseline screening, or unable to perform baseline bicycle exercise test.
- •Any of the following at the time of baseline screening: moderate or worse right heart dysfunction, requires dialysis, atrial fibrillation with ventricular rate > 100 bpm, systolic blood pressure greater than 170 mmHg (average of 3 measurements at baseline).
- •Evidence of precapillary pulmonary hypertension defined as PVR > 2 Wood units at rest, TPG > 15 at rest or with exercise, resting RA > 15 mmHg, or RA to PCWP ratio > 0.7 at rest and with exercise.
- •Anatomic anomaly that precludes creation of interatrial shunt.
结局指标
主要结局
The proportion of subjects who experience a major adverse cardiac or cerebrovascular event (MACCE) or systemic embolization.
时间窗: 1 month
The proportion of subjects who experience a composite MACCE or systemic embolization event.
次要结局
- Echocardiogram evidence of interatrial shunt with left to right atrial flow(1 month)
研究者
研究点 (1)
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