Short Term Changes of Left Atrial Function and Quality of Life in Patients With Atrial Fibrillation After Left Atrial Appendage Occlusion
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- quality of life assessed
研究概览
简要总结
A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation.
详细描述
A total of 105 patients with atrial fibrillation (AF) are scheduled to receive surgical treatment and will be divided into three groups. Left atrial appendage occlusion (LAAC), three-dimensional mapping guided radiofrequency ablation and LAAC combined radiofrequency ablation (1:1:1) were performed respectively. All patients were examined by real-time three-dimensional and two-dimensional ultrasound before operation, 1 and 3 months after operation to measure left atrial (LA) function. All ultrasound data will be stored and the professional director of the ultrasound room will be invited for quantitative analysis. The ultrasound indexes include: left atrial diameter, left atrial ejection fraction, etc. All patients underwent transesophageal echocardiography before operation and 3 months after the operation. Results two experienced ultrasound doctors judged whether there was left atrial thrombus, residual shunt and instrument surface related thrombus. The routine blood test and high-sensitivity C-reactive protein were performed in all patients before operation, 1 day and 1 month after operation. B-type natriuretic peptide was detected in all patients before operation and 1 day, 1 month and 3 months after operation. All patients underwent 6-minute walking test and quality of life score before operation, 1 and 3 months after operation. At the same time, the thickness of crista was measured in all patients. This study will clarify the changes of left atrial function and biochemical quality in patients with AF after LAAC. In addition, this study also observed the effect of radiofrequency ablation combined with LAAC on left atrial function and evaluated whether one-stop surgery has more advantages than simple occlusion or ablation, and analyzed the above results. The patients were followed up for an average of three months to analyze the changes of left atrial function, quality of life and embolism events.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AF lasting for more than one year;
- •Antiarrhythmic drugs are ineffective;
- •Age of patients is less than 80 years old;
- •Cha2ds2-vasc score ≥ 2;
- •Not suitable for long-term oral anticoagulants.
排除标准
- •Patients with a history of atrial thrombosis or valvular heart disease (moderate or severe valve stenosis or severe valve regurgitation);
- •Patients undergoing prosthetic heart valve replacement;
- •Pregnant women;
- •Patients with previous liver and kidney diseases, malignant tumors or blood system diseases.
研究组 & 干预措施
Left atrial appendage closure group
干预措施: Left atrial appendage closure group (Procedure)
Radiofrequency ablation group
干预措施: Radiofrequency ablation group (Procedure)
LAAC combined with radiofrequency ablation group
干预措施: LAAC combined with radiofrequency ablation group (Procedure)
结局指标
主要结局
quality of life assessed
时间窗: 1- 3 month
Shot Form 36 Health Survey Questionnaire：the higher the patient's score, the better the quality of life
changes of 6-minute walking test
时间窗: 1- 3 month
6-minute walking test in meter
Left atrial function of postoperative left atrial appendage occlusion detected
时间窗: 1- 3 month
Transthoracic ultrasound
次要结局
- Residual shunt after transcatheter closure of left atrial appendage detected(1-3 month)
- device-related thrombus after transcatheter closure of left atrial appendage detected(1-3 month)
- C creative protein(1-3 month)
- B natriuretic peptide assessed(before and 3 month after operation)
研究者
Ruiqin xie
director of cardiology department
The Second Hospital of Hebei Medical University