NCT06605794招募中不适用
A Prospective, Multi-center Study to Evaluate the Safety and Efficacy of FreeFlow Percutaneous Atrial Septal Shunt in Patients With Idiopathic Pulmonary Arterial Hypertension
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月11日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- All-cause mortality at 6 months
研究概览
简要总结
The goal of this clinical trial is to explore the safety and efficacy of the FreeFlow percutaneous atrial septal shunt for treatment of idiopathic pulmonary arterial hypertension. The main questions it aims to answer are:
- Is the FreeFlow percutaneous atrial septal shunt safe to use in patients with idiopathic pulmonary arterial hypertension?
- Does the FreeFlow percutaneous atrial septal shunt reduce all-cause mortality and readmission in patients with idiopathic pulmonary arterial hypertension, and how effective is it? Thirty subjects who met the inclusion and exclusion criteria were selected for selective implantation of FreeFlow percutaneous atrial septal shunts after balloon atrial septostomy.
Participants will:
- underwent balloon atrial septostomy and FreeFlow percutaneous atrial septal shunt implantation.
- will be followed up at 24 hours after shunt implantation or before discharge, 1 month, 3 months, 6 months and 12 months.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤ age ≤70 years old, female or male;
- •10 mmHg≤ mean right atrial pressure (mRAP) ≤20 mmHg;
- •The subjects had severe idiopathic pulmonary hypertension (mean pulmonary arterial pressure > 45 mmHg);
- •WHO grade III or IV;
- •NT-proBNP≥650 ng/L;
- •The subjects were informed of the nature of the study and agreed to all the requirements for participating in the study. They signed the informed consent form and agreed to complete the follow-up and the examinations required for the follow-up.
排除标准
- •Local or systemic sepsis or other acute infection;
- •Severe coagulopathy;
- •Allergy to nickel and/or titanium and/or nickel/titanium-based materials;
- •Patients with contraindications to antiplatelet, coagulant or thrombotic therapy;
- •Intolerance to contrast media;
- •Have participated in other drug or device clinical trials during the same period;
- •Glomerular filtration rate (GFR) < 50 mL/min;
- •Patients with severe liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal);
- •The patient had malignant arrhythmia;
- •The patient did not receive standardized drug therapy (triple sequential therapy) according to the Chinese guidelines for the diagnosis and treatment of pulmonary hypertension within 3 months;
- •Women who are pregnant, planning to become pregnant (within 12 months) or breastfeeding;
- •Severe restrictive or obstructive lung disease;
- •Implanted atrial septal defect (ASD)/ patent foramen ovale (PFO) closure device;
- •Left ventricular ejection fraction (LVEF) <50%;
- •SpO2 < 90% without oxygen inhalation (pulse measurement);
- •The anatomical structure of the heart is abnormal, and the shunt cannot be implanted on the atrial septum;
- •Other circumstances in which the patient was deemed by the investigator to be ineligible for inclusion in the trial.
结局指标
主要结局
All-cause mortality at 6 months
时间窗: 6 months
All-cause mortality at 6 months
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension
时间窗: 6 months
Rehospitalization rates associated with exacerbation of pulmonary arterial hypertension within 6 months
次要结局
- Effective shunt rate at the end point(12 months)
- Shunt Success rate(12 months)
- The WHO functional class was changed 12 months after operation(12 months)
- Changes in NT-pro BNP at 12 months after surgery(12 months)
- The change of exercise capacity (6min walking test) was observed 12 months after operation(12 months)
- The change of subjects' Kansas City Cardiomyopathy Quality of Life Questionnaire score at 12 months after surgery(12 months)
- Cumulative number of readmissions associated with exacerbation of pulmonary hypertension at 12 months after surgery(12 months)
- Device-related Adverse Event Rate (DSAE)(through study completion, an average of 1 year)
- Serious Adverse Event Rate (SAE)(through study completion, an average of 1 year)
研究者
研究点 (1)
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