Left Atrial Appendage Electrical Isolation in Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Atrial Fibrillation, Left Atrial Appendage, Left Atrial Appendage Occlusion, Catheter Ablation

Intervention / Treatment
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* Procedure: Catheter ablation and left atrial appendage occlusion
* Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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; LVEF<30%; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Left Atrial Appendage Electrical Isolation with One-stop treatment of atrial fibrillation<br>The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion and additional left atrial appendage electrical isolation operation. | Procedure: Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion<br>* These patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion.<br>|
| Other: One-stop treatment of atrial fibrillation<br>The patients received routine catheter ablation of atrial fibrillation with left atrial appendage occlusion. | Procedure: Catheter ablation and left atrial appendage occlusion<br>* The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation recurrence | outside the 3-month blank period after surgery, ECG and Holter recorded rapid atrial arrhythmia greater than 30S. | one year after operation | 
| Stroke/TIA | 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. | one year after operation | 
| Systemic embolism | 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. | one year after operation | 
| Hospitalization rate due to heart failure | 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. | one year after operation | 
| Cardiovascular death | The death of a patient due to cardiac structure, function, coronary artery disease, and arrhythmia can be diagnosed in combination with clinical practice. | one year after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left Atrial Appendage Electrical Isolation, Atrial Fibrillation, Catheter Ablation