An Early Feasibility Study Evaluation of an Implant Free Interatrial Shunt to Improve Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 12
- 主要终点
- Measure of major safety events in the periprocedural timeframe
研究概览
简要总结
The purpose of this early feasibility study is to evaluate the safety and feasibility of the device for percutaneous shunting of the interatrial septum and improvement of heart failure related symptoms. The primary goal is to determine if the device is safe to use. The findings from this study may be used to refine the intended patient population, the design of the device, or develop a subsequent randomized study.
详细描述
This is a prospective, multicenter, single-arm early feasibility study (EFS) to evaluate the safety of the InterShunt PAS-C System in subjects with heart failure, and the feasibility of PAS-C to improve heart failure related symptoms. The device is used to create an interatrial shunt by removing septal tissue to reduce left atrial pressure. There is no permanent implant. Enrollment will include 20 subjects with documented heart failure who may benefit from the reduction of left atrial pressure. The primary objective of this study is to characterize the safety of using the PAS-C System by evaluating the proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization through one month after the procedure. The findings from this study will be used to develop a subsequent pivotal study.
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
- •NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit.
- •At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months.
- •Receiving maximally tolerated guideline directed medical therapy for Heart Failure management.
- •LVEF ≥ 20% and ≤ 40% according to baseline echocardiography.
- •Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure.
排除标准
- •Any of the following within the prior 6 months: Stroke, thromboembolism, severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 1.8 L/min/m2, LVEDD > 8 cm, or received inotropic therapy for LVEF less than 20%.
- •Any of the following within the prior 3 months: Myocardial infarction percutaneous cardiac intervention, CABG, on cardiac transplant list, cardiac resynchronization therapy implant, AICD implant, or indicated for coronary revascularization at the time of enrollment.
- •Transseptal procedure or percutaneous cardiac intervention planned within the next 6 months.
- •Chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease.
- •Patent foramen ovale (PFO) device or atrial septal defect (ASD) device.
- •Anatomic anomaly that precludes creation of interatrial shunt.
研究组 & 干预措施
PAS-C System
The PAS-C System is a catheter designed to remove a small section of septal tissue in the interatrial septum to treat heart failure patients without the need for a permanent implant.
干预措施: PAS-C System (Device)
结局指标
主要结局
Measure of major safety events in the periprocedural timeframe
时间窗: Through one month post procedure
Proportion of subjects who experience a major adverse cardiac or cerebrovascular event or systemic embolization
次要结局
未报告次要终点