Study on the Significance of Auricular Clip in Prevention and Treatment of Valvular Heart Disease Atrial Thrombosis and the Related Precision Treatment Technique
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 118
- 主要终点
- Clinical success rate of auricular clip
研究概览
简要总结
To evaluate the safety and clinical efficacy of left atrial appendage in the prevention of thrombus in patients with valvular heart disease, to improve the product according to clinical conditions, to achieve clinically accurate treatment, and to establish the heart valve, the usefulness and universality of Warfarin's anticoagulant model were verified by the specimen library
详细描述
Atrial fibrillation (AF) is a common arrhythmia. The risk of ischemic stroke in AF patients is 4-5 times higher than that in non-af patients, and leads to nearly 20% mortality and nearly 60% disability. Atrial fibrillation is associated with valvular disease and atrial fibrillation in about 30-70% of patients with valvular heart disease. Left atrial thrombus occurs in 15-25% of patients with atrial fibrillation. More than 90% of patients with atrial thrombus is located in the left atrial appendage. In patients with valvular atrial fibrillation, the left atrial appendage is clamped at the same time of valvular surgery to avoid recurrence of atrial thrombus-related stroke. In this clinical trial, the left atrial appendage was used to clamp the prethrombotic site of the heart to prevent stroke and improve the prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with valvular heart disease aged between 18 and 75
- •Valvular heart disease [Cardiovascular Surgery Volume, Clinical Diagnosis and Treatment Guidelines, Chinese Medical Association (2011 edition)]
- •Preoperative cardiac function grade II-III (NYHA), no operation-related contraindications
- •Understand the nature of this study, agree to participate in all terms of this study, sign informed consent, agree to accept postoperative treatment plan and follow-up requirements, and cooperate to complete follow-up
排除标准
- •Patients whose left atrial appendage has been resected or occluded
- •She had a history of open heart surgery with extensive adhesion of the pericardium
- •Patients cannot be returned due to other reasons
- •Failed to reach the end point in clinical trials of other drugs or devices
- •X-ray is contraindicated or not suitable for TEE examination
- •Those who are considered unsuitable for the clinical trial by the investigator
结局指标
主要结局
Clinical success rate of auricular clip
时间窗: 12 months
Rate of patients without ischemic stroke, TIA, or systemic embolism 12 months after cardiac and auricular clipping
Success rate of auricular clip clipping
时间窗: 12 months
Success rate of auricular clip clipping
次要结局
未报告次要终点