Assessment of Reconstruction and Inverse Reconstruction in Right Atrium by by Multimodal Echocardiographic Techniques for Atrial Fibrillation Patients Before and After Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
研究概览
简要总结
The purpose of the study is to assess the reconstruction and inverse reconstruction in right atrium by speckle tracking echocardiography combined with real-time three dimensional echocardiography for atrial fibrillation patients before and after radiofrequency ablation (RFCA)
详细描述
The prevalence of atrial fibrillation (AF) has increased in recent years. The construction and function of right atrium haven't shown clearly before and after radiofrequency ablation (RFCA).The purpose of the study is to investigate whether RFCA can lead to inverse reconstruction of right atrium for atrial fibrillation patients, which diagnosing by speckle tracking echocardiography combined with real-time three dimensional echocardiography. All patients will be followed up for 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With a history of paroxysmal Af (PAF) and PAF record within 6 months prior to ablation, confirming at least one of the following findings: AF lasting for ≥30 s recorded in Holter or 12-lead ECG.
- •No response to more than one antiarrhythmic drug, or unwilling to receive longterm drug treatment.
- •Can provide informed consent form expressing willingness to participate in the study and comply with follow-up tests and evaluation procedures.
- •Aged 18-80 years.
排除标准
- •With acute diseases, such as acute phase after myocardial infarction (within 3 months), within 3 months after acute heart failure or new cerebral infarction;
- •In the list of heart transplantation;
- •Expected survival less than 1 year;
- •With other hemorrhagic diseases and anticoagulant therapy is not allowed;
- •Thrombosis in left atrium;
- •Heart failure, New York Heart Association(NYHA) III/IV or eject fraction(EF)<40%;
- •Patients with uncontrolled cancer;
- •Significant hepatic or renal impairment (and/or alanine transaminase(ALT) or Aspartate transaminase(AST) >2 times upper limit of normal, creatinine clearance rate(CCr)<50%);
- •Previous catheter radiofrequency ablation for AF or cardiac surgery;
- •Pregnant and lactating women, women who plan to become pregnant, or women of child bearing age not using reliable contraceptive measures.
研究组 & 干预措施
patients with AF
Before radiofrequency ablation (RFCA)
干预措施: radiofrequency ablation (RFCA) (Procedure)
Assigned Comparisons
After radiofrequency ablation (RFCA)
干预措施: radiofrequency ablation (RFCA) (Procedure)
结局指标
主要结局
Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients
时间窗: In one week before RFCA
次要结局
- Remodeling in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients(In one week after RFCA)
- Adverse event that is related to RFCA, such as the incidence of cardiac tamponade (%) was obtained by echocardiography(In one week after RFCA)
- Inverse reconstruction in right atrium measured by speckle tracking echocardiography combined with real-time three dimensional echocardiography in AF patients(At six months after RFCA)
研究者
Yi Yu
vice professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine