A Prospective Randomized Controlled Study of Additonal Left Atrial Appendage Electrical Isolation in Catheter Ablation Combined With Left Atrial Appendage Occlusion of Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Atrial fibrillation recurrence
研究概览
简要总结
This project intends to enroll patients with persistent atrial fibrillation who are planning to undergo catheter ablation of atrial fibrillation. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. We are intend to evaluate the safety and effectiveness of one-stop operation of left atrial appendage electrical isolation combined with left atrial appendage occlusion in the treatment of persistent atrial fibrillation.
详细描述
This project intends to enroll patients with persistent atrial fibrillation who are planned to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery, and randomly allocate them to the experimental group and the control group at a ratio of 1:1. The two groups of patients were routinely performed atrial fibrillation pulmonary vein isolation and linear ablation with left atrial appendage occlusion. The experimental group received additional left atrial appendage electrical isolation before the left atrial appendage occlusion, and the control group did not perform left atrial appendage electrical isolation. Follow-up for 1 year, compare the differences in the recurrence rate of atrial fibrillation between the two groups of patients, and further compare the differences in clinical events such as stroke, systemic embolism, hospitalization due to heart failure, and cardiovascular death.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-85 years old;
- •Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥ 1 week), and is ineffective to one or more anti-arrhythmic drugs;
- •CHA2DS2-VASc score ≥ 2 points;
- •The patient is ready to undergo atrial fibrillation catheter ablation and left atrial appendage closure surgery;
- •Provide an informed consent form that is willing to participate in the research, follow-up trials and evaluation procedures.
排除标准
- •Past left atrial appendage occlusion, atrial fibrillation catheter ablation or surgical ablation history;
- •There are plans for cardiac surgery within 90 days;
- •Stroke/transient ischemic attack occurred within 30 days;
- •Have had atrial septal defect repair or have an ASD/PFO occluder in the body;
- •Heart failure NYHA heart function grade IV;
- •Combined with other serious diseases, the life expectancy is less than 2 years;
- •Within 6 months after cardiac revascularization or other cardiac surgery;
- •Women who are pregnant, breastfeeding, planning to become pregnant, or women of childbearing age who have not adopted reliable contraceptive methods;
- •Obviously abnormal liver and kidney function and coagulation function;
研究组 & 干预措施
Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation
The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation.
干预措施: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion (Procedure)
One-stop treatment of atrial fibrillation
The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion.
干预措施: Catheter ablation and left atrial appendage occlusion (Procedure)
结局指标
主要结局
Atrial fibrillation recurrence
时间窗: one year after operation
outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S.
Stroke/TIA
时间窗: one year after operation
Patients may have cerebral ischemia, such as sudden limb movement and sensory disturbance, aphasia, transient blindness in one eye, etc., disturbance of consciousness, or symptoms of vertebral artery ischemia, such as vertigo, tinnitus, hearing impairment, diplopia, Unsteady gait and difficulty swallowing, etc., patients may have obvious infarcts in the brain, which can be confirmed clinically by CT or MRI.
Hospitalization rate due to heart failure
时间窗: one year after operation
During the follow-up period, patients need hospitalization for heart failure, including acute heart failure, acute exacerbation of chronic heart failure, etc., which can be combined with clinical symptoms, signs, biochemical examinations (such as NT-proBNP) and cardiac ultrasound Wait for a clear diagnosis.
Cardiovascular death
时间窗: one year after operation
The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice.
Systemic embolism
时间窗: one year after operation
The clinical manifestations or evidence of embolism in the blood vessels of the system, including renal artery, splenic artery, mesenteric artery, etc. during the follow-up of the patient, and relevant examinations can be used to confirm the diagnosis.
次要结局
未报告次要终点