Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Population

Study Overview
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Brief Summary
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Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.

Detailed Description
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the investigators aimed to observe the clinical outcome of combining cryoballoon ablation (CBA) with left atrial appendage closure (LAAC) in drug-refractory non-valvular atrial fibrillation patients, who have high risk of stroke or hemorrhage, or contraindication of long-term oral anticoagulants (OACs). The combined procedure was completed using CBA following LAAC. Generally, 3-month OACs, following 3-month double antiplatelet therapy, and lifelong single platelet therapy was recommended as antithrombotic regimen. At 3rd,6th,12th and every year after since the procedure, Holter and transoesophageal echocardiography monitoring, and outpatient follow-up was applied to every patient. The safety was evaluated by all-cause mortality, peri- and postprocedural complications. While the efficacy was evaluated through the freedom of atrial arrhythmia, stroke incidence, and withdrawal of OACs.

Official Title
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Combining Left Atrial Appendage Closure With Cryoballoon Ablation in Chinese Atrial Fibrillation Population

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Combination Product: cryoballoon ablation combining with left atrial appendage closure


Participation Criteria
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Eligibility Criteria
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Drug refractory non-valvular paroxysmal atrial fibrillation patients, Inclusion Criteria: CHA2DS2-VASc score≥2 or HAS-BLED score≥3, having contraindications to long-term oral anticoagulants (OACs), refuse OAC therapy despite explanation. Exclusion Criteria: thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE), oversized LA (LA diameter>65mm by TTE) or LAA (LAA opening>35mm) through TEE, pericardial effusion (≥4mm by TTE or TEE), hemodynamic unstable patients, patients with active hemorrhagic diseases, ischemic or hemorrhagic stroke within 30 days.

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| combined procedure group<br>patients underwent cryoballoon ablation and left atrial appendage closure | Combination Product: cryoballoon ablation combining with left atrial appendage closure<br>* cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of atrial arrhythmia | The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Incidence of stroke | the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | Death event due to any cause | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Cardiovascular death | death due to cardiovascular cause | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Major hemorrhagic events | Intracranial hemorrhage, gastrointestinal bleeding, or any overt bleeding with hemoglobin drop ≥3 to 5 g/dL. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Myocardial infarction | Diagnosed myocardial infarction with or without ST segment elevation. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Peripheral vascular embolism | Arterial or venous thrombosis except cardiac or cerebral vascular embolism confirmed by imaging examination. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Rehospitalization due to cardiovascular events | Inpatient admission or emergency department admission with cardiovascular causes. | Since the start of the procedure to 5 years. | 
| Redo-ablation | Ablation intended to treat recurrent atrial arrhythmia | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Withdrawal of oral anticoagulants | The proportion of patients stop oral anticoagulation therapy including warfarin, dabigatran, or rivaroxaban. | since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 
| Residual flow | Residual flow between LAAC device and LAA measured by TEE | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | 
| LAAC device position | displacement of LAAC device evaluated by TEE | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | 
| Device related thrombus | Thrombus surrounding or attached to the LAAC device detected by TEE | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | 
| Atrioesophageal fistula | Fistula between left atrium and esophagus detected by TEE. | Instantly after the procedure, and the 3rd month after the procedure. Evaluation at 1 year will be arranged according to the last TEE result. | 
| Pericardial effusion | Any amount of pericardial effusion detected by TTE or TEE | Since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese, Combined procedure, Cryoballoon ablation, Left atrial appendage closure