Flow Regulation by Opening the Septum in Patients With Heart Failure (FROST-HF) Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- 6MWT
研究概览
简要总结
To investigate the safety and efficacy of a novel atrial flow regulator (AFR) device in patients with heart failure and preserved ejection fraction.
详细描述
The study will allow us to demonstrate the safety of the AFR device as well as determine the clinical response of the therapeutic intervention. In addition, the invasive exercise hemodynamics will provide objective data for the changes in the cardiac hemodynamics and delineate underlying mechanisms of creating a permanent inter atrial shunting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age > 40 years
- •LVEF > 45% documented within the last 3 months.
- •NYHA class ≥II status or 6MWT distance <80% predicted.
- •Left atrial enlargement
- •PCWP ≥25 mmHg during supine bicycle exercise on hemodynamic monitoring.
- •Left atrial pressure greater than right atrial pressure by ≥5 mmHg on hemodynamic monitoring.
排除标准
- •Recent MI, PCI or CABG
- •Untreated CAD with indication for revascularization
- •Recent stroke, pulmonary embolism or major surgery
- •Uncontrolled atrial fibrillation
- •H/O cardiomyopathy (hypertrophic, restrictive, infiltrative) or pericardial disease
- •Inability to perform a 6-minute walk test.
- •Clinically significant valvular disease
- •Uunsuitable for study participation at investigator discretion.
- •Severe COPD, Anemia or morbid obesity
- •Uncontrolled hypertension
- •Women of child bearing age
- •RA pressure >15 mmHg or PVR >4 wood units
研究组 & 干预措施
Control arm
Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
干预措施: Sham procedure (Device)
AFR arm
Implantation of Occlutech atrial flow regulator (AFR) device
干预措施: AFR implantation (Device)
结局指标
主要结局
6MWT
时间窗: 12 months
Six minute walk test at 12 months
次要结局
- Congestive heart failure (CHF)(12 months)
- MACE(12 months)
- Cardiac death(12 months)
- Quality of Life (QOL)(12 months)