Left Atrial Appendage Closure in Combination With Catheter Ablation

Study Overview
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Brief Summary
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This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

Detailed Description
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This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation. This study will be conducted in accordance with the following procedures: Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

Official Title
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The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: left atrial appendage closure and catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of paroxysmal/persistent/longstanding persistent atrial fibrillation Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs; With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3 Provide informed consent to participate in the study; Between 18-90 years Exclusion Criteria: myocardial infarction within 3 months Stroke or systemic embolism within 3 months Plan to receive heart transplantation; Life expectancy less than 1 year; Severe bleeding diseases that cannot be treated with short-term anticoagulants; With left atrial or left atrial appendage thrombus; With uncontrolled malignant tumor ; Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr <50%); Women who are pregnant, or breastfeeding. Other conditions not suitable to the combined procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LAAC plus Catheter ablation<br>Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment. | Procedure: left atrial appendage closure and catheter ablation<br>* Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF). Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.<br>* Other names: left atrial appendage occlusion; radiofrequency ablation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stroke/TIA/systemic embolism | The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis. | long-term after the procedure. | 
| Major bleeding | The incidence of major bleeding in the participants will be reported. | long-term after the procedure. | 
| Death | all-cause death | long-term after the procedure. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maintenance of sinus rhythm | This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias. | after the procedure outside the 3-month blanking period | 
| procedure-related complications | These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications. | after the procedure. | 
| Heart failure rehospitalization | acute heart failure leading to hospitalization | after the procedure. |