Personalized Atrial Septostomy With Combined Use of Radiofrequency-ablation and Balloon-dilation: First-in-human Study in Heart Failure
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Clinical change
研究概览
简要总结
This study aims to investigate the safety and efficacy of personalized atrial septostomy (PAS) with combined use of radiofrequency-ablation and balloon-dilation (CURB) in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF).
详细描述
Atrial septostomy is an important palliative therapy in heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) . Though the safety of balloon atrial septostomy (BAS) is satisfactory, the incidence of spontaneous closure is higher, which limits the clinical utilization of this procedure. The device-implantation improves the long-term patency. However, the created fenestration is limited with fixed size and it is further complicated with the potential device-related complications.
Radiofrequency catheter ablation (RFA) has the potential to cause irreversible damage around the rim of fenestration created with BAS, which might prevent the re-adhesion of the septal remnants. In addition, RFA on fossae ovalis might reduce the elastic recoil of local tissue and contribute to create larger inter-atrial fenestration with same BAS procedure. Therefore, the combined use of radiofrequency-ablation and balloon-dilation (CURB) might become a novel procedure to create a stable inter-atrial fenestration.
In this study, the adult patients who have HFrEF and HFpEF refractory to medical therapy may be eligible for this 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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Symptomatic heart failure in NYHA class III or IV ambulatory;
- •Optimal medical therapy of heart failure according to European Society of Cardiology (ESC) guidelines for last 6 months;
- •LVEF ≥ 45%;
- •Elevated left heart filling pressures: left ventricular end-diastolic pressure (LVEDP) or pulmonary capillary wedge pressure (PCWP) ≥ 18 mmHg at rest;
- •LVEDP or PCWP-Mean right atrial pressure (MRAP) ≥ 5 mmHg;
- •Systolic blood pressure ≥ 90 mmHg.
排除标准
- •Acute infection or sepsis;
- •Intra-cardiac mass, thrombus or vegetation;
- •Evidence of right heart failure (TAPSE < 14 mm);
- •Pulmonary hypertension (PASP > 60 mmHg);
- •Associated atrial septal defect or large patent foramen ovale with significant left to right shunt in rest;
- •TIA or stroke within the last 6 months;
- •Thromboembolic events within the last 6 months;
- •Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy as cause of heart failure;
- •Valvular diseases requiring therapy according to current ESC guidelines;
- •Life expectancy < 1 year for non-cardiovascular reasons.
研究组 & 干预措施
CURB procedure
Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (CURB)
干预措施: Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation (Procedure)
结局指标
主要结局
Clinical change
时间窗: 12 months
Distance in 6 minutes walk test
The size of created-fenestration
时间窗: 12 months
The change of created-fenestration size evaluated with echocardiography
次要结局
- Change of PAWP or MLAP at rest(12 months)
- The percent of subjects who experience major adverse cardiac and cerebrovascular events (MACCE)(12 months)
- Change of cardiac remodeling(12 months)
- Myocardial remodeling(12 months)