Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Previous evidence indicated that the outcomes of both video-assisted thoracoscopic surgical ablation and percutaneous radiofrequency ablation therapy for persistent atrial fibrillation (AF) were unsatisfied. Recently, hybrid ablation therapy for AF had encouraging outcomes. However, there were no randomized, controlled clinical studies to prove the effectiveness of this new strategy. This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Detailed Description
-----------------
This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.

Official Title
-----------------
Comparison Between One-stage Hybrid Ablation and Thoracoscopic Surgical Ablation for Intractable Atrial Fibrillation

Conditions
-----------------
Persistent Atrial Fibrillation

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with at least one anti-arrhythmic drugs Persistent AF lasting more than 1 year or with a left atrial diameter>50mm Exclusion Criteria: Previous percutaneous catheter ablation or surgical ablation Presence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease) Left atrial diameter>60mm Previous thoracic or lung operation Left atrial thrombosis or left atrial appendage thrombosis Chronic obstructive pulmonary disease (COPD) (Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC)<70%、FEV1<50% anticipated value) Bilateral carotid artery stenosis>80% Refuse to participate in this study
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid ablation group<br>Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation. | Procedure: Hybrid ablation<br>* This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.<br>|
| Active Comparator: Thoracoscopic surgical ablation group<br>Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set. | Procedure: Thoracoscopic surgical ablation<br>* This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate without any recurrence of AF | Without detections of AF (episodes longer than 30 seconds) | At 12-month after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burden of AF | Burden of AF according to Tele-ECG-Card lasting for one week | At 12-month after intervention | 
| Quality of life score | Measured with questionnaire of AF effect on Quality of Life | preoperative and 12-month after intervention | 
| Adverse events | Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events. | 12 months follow up | 
| Left atrial function | left atrial ejection fraction and left atrial expansion index | preoperative and postoperative | 
| postoperative complications | perioperative complication of catheter ablation and thoracoscopic surgical abaltion | 30 days after operation | 
| Survival rate without any recurrence of atrial tachyarrhythmia | Survival rate without AF, atrial flutter or atrial tachycardia will be defined by absence of any of these electrocardiographically documented events lasting > 30 seconds. | At 12-month after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hybrid ablation, Thoracoscope