NCT05360771尚未招募不适用
A Prospective, Multicenter, Randomized Controlled Clinical Study on the Safety and Effectiveness of the SnowyTM PFO Closure System in Plugging Patent Foramen Ovale
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- The success rate of PFO effective occlusion
研究概览
简要总结
To evaluate the safety and effectiveness of the SnowyTM PFO closure system in plugging patent foramen ovale
详细描述
A prospective, multicenter, randomized controlled clinical trial is conducted to evaluate the safety and effectiveness of PFO closure system produced by Hangzhou Dinova EP Technology Co., Ltd.., Ltd. in closing patent foramen ovale (PFO). 242 patients are expected to be selected. They are randomly divided into the PFO closure system treatment group (121 cases) and the Chinese medicine Shengjie Cardi-o-fix PFO occluder treatment group (121 cases) according to 1:1. All patients will be followed up to 7 days after operation or before discharge, 1 month, 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 65 years old, regardless of gender
- •Transthoracic echocardiographic contrast echocardiography (cTTE) confirmed the presence of PFO and at least moderate (see above definition) RLS (in Valsalva active/resting state)
- •Existence of at least one of the following conditions： 1) Unexplained stroke or TIA 2) intractable or chronic migraine
- •The subjects are informed of the nature of the study and agreed to all requirements for participation in the study, signed the informed consent form, and agree to complete the follow-up and follow-up examination
排除标准
- •Patients have definite causes of stroke unrelated to the PFO
- •RLS caused by other causes, such as atrial septal defect or pulmonary arteriovenous shunt
- •Atrial fibrillation or atrial flutter
- •Mitral and aortic stenosis or severe regurgitation
- •Dilated cardiomyopathy, hypertrophic cardiomyopathy, restrictive cardiomyopathy
- •Active endocarditis or other untreated infectious diseases
- •Left ventricular ejection fraction (LVEF) < 40%, or NYHA cardiac function grade III-IV
- •Uncontrollable hypertension
- •Previous intracardiac surgery
- •Myocardial infarction or unstable angina pectoris within 6 months
- •Contraindications to anticoagulants or antiplatelet drugs
- •High risk of bleeding
- •severe liver function impairment（alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal value）
- •Serum creatinine greater than 2 times the upper limit of normal or with any history of renal dialysis or renal transplantation
- •Severe pulmonary disease including pulmonary hypertension (clinical diagnosis)
- •Nickel or contrast allergy
- •Active or planned (within 12 months) pregnancy, or lactating female patients
- •Malignant tumors or other serious diseases resulting in a life expectancy of less than 12 months
- •Psychiatric conditions that may interfere with medical compliance and compliance with follow-up
- •Concomitant participation in other clinical trials
- •The investigator determines that the patient is unsuitable because of reasons not listed but thought to interfere with safe trial participation
结局指标
主要结局
The success rate of PFO effective occlusion
时间窗: 6 months after the procedure
The amount of right to left shunt (RLS) confirmed by imaging examination after occluder implantation is grade 0-I
次要结局
- Complete closure rate(6 months after the procedure)
- Number of Participants with Procedural success(immediately after the procedure)
- Number of Participants with Device success(immediately after the procedure)
- All-cause mortality during follow-up(5 years after the procedure)
- All-cause stroke during follow-up(5 years after the procedure)
- Migraine Headache Impact Test (HIT-6) scores 6 months after operation (compared with baseline)(6 months after the procedure)
- Incidence of serious adverse events(5 years after the procedure)
- Incidence of device-related adverse events(5 years after the procedure)
研究者
研究点 (1)
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