Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 700
- 试验地点
- 237
- 主要终点
- Composite Primary Endpoint
研究概览
简要总结
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
- •NYHA Class II, III or ambulatory IV
- •Exercise right heart catheterization*
- •Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
- •Exercise PVR < 1.8 WU
- •Ongoing stable GDMT
排除标准
- •Advanced heart failure
- •Presence of a pacemaker
- •Evidence of right heart dysfunction
研究组 & 干预措施
Treatment
Subjects randomized to the treatment arm will undergo cardiac imaging, femoral vein access and receive the Alleviant ALV1 System device procedure.
干预措施: Alleviant ALV1 System (Device)
Control
Subjects randomized to the control arm will undergo cardiac imaging and sheath placement in femoral vein.
干预措施: Sham-Control (Other)
结局指标
主要结局
Composite Primary Endpoint
时间窗: 12-month
The primary endpoint is a composite of mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
次要结局
未报告次要终点