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临床试验/NCT03276169
NCT03276169已完成不适用

Left Atrial Function Changes After Left Atrial Appendage Closure in Patients With Persistent Atrial Fibrillation

Ruiqin xie1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2017年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
1
主要终点
Left atrial function of postoperative left atrial appendage occlusion detected

研究概览

简要总结

A total of 105 patients with persistent atrial fibrillation(AF), that lasting longer than one year and planned to undergo surgical treatment, will be allocated into three groups. These patients will receive left atrial appendage closure(LAAC), radiofrequency ablation under the guidance of 3D mapping and LAAC combined with radiofrequency ablation, respectively (allocation ratio, 1:1:1). Real-time 3D ultrasound and 2D ultrasound examinations and measurement of left ventricle(LV) and left atrial(LA) function are carried out for all patients before the operation, and at 1, 2, 3 and 4 weeks and 2, 3, 6, 9 and 12 months after the operation. All ultrasound data will be stored and a professional director from the ultrasound room will be invited for quantitative analysis. Indicators for ultrasonography include: LV ejection fraction(LVEF), LV end-diastolic volume, Stroke volume, left atrial anterior and posterior diameter, left atrial volume, left atrial volume index, mitral e ", E peak, A peak, velocity time integral (VTI), left atrial ejection fraction, left atrial strain, and strain rate. Blood samples are extracted in all patients to detect type B natriuretic peptide before the operation and at 1, 2, 3 days and 1,3,6,12 months after the operation. Blood samples are extracted in all patients to detect routine blood, coagulation, D-D dimmer,Inflammatory markers (hsCRP) and other biochemical parameters before the operation and at 1, 2, 3 and 4 weeks and 1, 2, 3,6and 12 months after the operation. At the same time in operation LA pressure in all patients will be measured preoperatively and postoperatively. This study will clarify the short-term and long-term changes of LA pressure and function of patients with persistent AF after LAAC, and whether changes in left atrial pressure and function are related to inflammation indicators. This study will also to observe whether the coagulation indexes changed after LAAC that can be used to know whether the LAAC activates the coagulation system. In addition, this study to investigate the effects of radiofrequency ablation combined with LAAC on left atrial pressure and function, changes of blood coagulation and inflammatory markers, and to analyze the above findings. At an average follow-up of one year, changes in left atrial function, inflammation, coagulation, and embolic events were analyzed early (3 months after surgery) and late (1 years after surgery).

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
Double (Participant, Outcomes Assessor)

盲法说明

The researchers will participate in the operation to record operative parameters such as LA pressure. Other researchers including follow-up personnel and the ultrasonic data analyst are uninformed about the random situation of the patients (patient information is recorded according to the random number. Random numbers corresponding to the random allocation list are stored in the research center. After follow-up of the last patient is completed, the random allocation list is published by the random number designer; and the designer does not participate in the data collection and statistics.)

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •persistent atrial fibrillation episode occurs in the patient that lasting longer than one year,
  • •atrial fibrillation cannot be prevented in patients who orally take class I and III antiarrhythmic drugs,
  • •and patient age is <80 years.

排除标准

  • •patients with previous history of atrial fibrillation ablation, atrial thrombosis, or valvular heart disease (moderate and severe valvular stenosis, severe valvular regurgitation),
  • •patients who underwent prosthetic heart valve replacement,
  • •pregnant women,
  • •patients with existing liver and kidney disease, malignant tumors or hematological system diseases.

研究组 & 干预措施

Radiofrequency ablation group

Other

干预措施: Radiofrequency ablation (Procedure)

LAAC combined with radiofrequency ablation group

Experimental

干预措施: LAAC combined with radiofrequency ablation group (Procedure)

Left atrial appendage closure group

Experimental

干预措施: Left atrial appendage closure (Procedure)

结局指标

主要结局

Left atrial function of postoperative left atrial appendage occlusion detected

时间窗: 1-12 month

Transthoracic ultrasound

次要结局

  • Plasma biomarkers of inflammation assessed(1-12 month)
  • B natriuretic peptide assessed(1-12 month)
  • Coagulation index assessed(1-6 month)

研究者

发起方
Ruiqin xie
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ruiqin xie

director of cardiology department

The Second Hospital of Hebei Medical University

研究点 (1)

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