Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 3
- 主要终点
- Serious Adverse Device Events
研究概览
简要总结
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction.
详细描述
The study was a multi-center, non-randomized feasibility evaluation of the IASD System at three centers in three countries (Denmark, Australia, and Czech Republic). Relevant ethics committee and competent authority approvals were obtained. The study was conducted in accordance with the Declaration of Helsinki. The protocol required the treatment of a minimum of 5 patients, and allowed up to twenty patients to be enrolled.
The primary objective of the trial was to evaluate the safety and potential benefits of the IASD Device System in the treatment of patients with symptomatic heart failure with preserved ejection fraction, despite optimal medical management.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of HFpEF
- •Ejection Fraction of at least 45%
- •Imaging and hemodynamic evidence of HFpEF
- •History of exercise intolerance
- •Symptomatic despite optimal medical management
- •Signed study specific informed consent
排除标准
- •History of thromboembolic events
- •Significant structural heart disease or coronary artery disease
- •Contraindicated to study required medication
- •Right ventricular dysfunction
- •History of greater than mild restrictive or obstructive lung disease
- •Life expectancy less than one year for non-cardiovascular reasons
- •Known or suspected allergy to implant material
- •Fertile women
结局指标
主要结局
Serious Adverse Device Events
时间窗: One month
次要结局
未报告次要终点