Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation

Study Overview
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Brief Summary
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Hybrid ablation, as an emerging strategy for atrial fibrillation (AF) in recent years, shows encouraging outcomes in many medical centers. A lot of cases demonstrated hybrid ablation has higher success rate than surgical ablation on patients with persistent AF, especially long-standing persistent AF (LSPAF). But it is still lack of high level evidence to prove it. This study focus on patients with long-standing persistent atrial fibrillation (LSPAF). In order to compare the efficacy and safety of hybrid ablation (two-stage) versus thoracoscopic surgical ablation, a randomized, controlled clinical trial will be performed in the population of LSPAF patients.

Detailed Description
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In this study, all selected LSPAF patients will receive thoracoscopic surgical ablation. After 3 months of blanking-period, patients off antiarrhythmic therapy freedom from atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) will be divided into Hybrid group and Surgical group randomly and equally. Patients of Hybrid group will receive transcatheter endocardial electrophysiological mapping and catheter ablation after randomization subsequently. In followed 2 years, cardiovascular risk control will be recommended to 2 groups' patients. During the 2-year follow-up, 7d-Holter will be used to monitor patients' rhythm and cardiac conditions will be confirmed by transthoracic echocardiography (TTE). Physical examination and examinations mentioned above will be performed in 3 months, 6 months, 12 months, 18 months, 24 months and suspected recurrence.

Official Title
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Efficacy of Two-stage Hybrid Ablation or Thoracoscopic Epicardial Ablation for Long-standing Persistent Atrial Fibrillation: A Prospective, Randomized Controlled Trial

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Hybrid ablation
* Procedure: Thoracoscopic surgical ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Older than 18 years old. Nonvalvular and long-standing persistent atrial fibrillation confirmed by echocardiography and electrocardiography respectively. Written informed consent Exclusion Criteria: Secondary atrial fibrillation caused by other reversible diseases. Left atrial diameter >55mm confrimed by Transthoracic echocardiography. Intracardial mass or thrombus. Previous cardiac surgery. Uncontrolled heart failure or LVEF less than 30%. Severe chest wall deformity. Possibly pleural adhesion or pericardial adhesion caused by previous thoracic surgery, tuberculosis or constrictive pericarditis. Severe comorbidities (e.g. severe CAD, severe renal failure, severe liver failure). Life expectancy less than 2 years (e.g. patients with MODS or cancer) Unsuitable for radiation exposure (e.g. pregnancy)

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Two-stage hybrid abltaion<br>After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will receive percutaneous catheter ablation and recommendations about cardiovascular risk control. | Procedure: Hybrid ablation<br>* This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.<br>|
| Active Comparator: Thoracosopic surgical ablation<br>After thoracoscopic surgical ablation and 3 months of blanking-period, patients in this group will only receive recommendations about cardiovascular risk control. | Procedure: Thoracoscopic surgical ablation<br>* This intervention including thoracoscopic surgical ablation and cardiovascular risk control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial tachyarrhythmia recurrence | Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter. | 24 months after blanking-period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic atrial embolism | Including cerebral infarction and other peripheral atrial embolism | 24 months after blanking-period. | 
| Left atrial thrombus | New-onset left atrial thrombus confirmed by TEE or TTE | At 3months, 6months, 12months, 18months, 24months after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Hybrid ablation, Surgical ablation