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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.
This study is aimed to compare the outcomes of hybrid ablation with video-assisted thoracoscopic surgical ablation for persistent AF with enlarged left atrium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid ablation group | Experimental | Patients in this group will receive one-stop intervention with totally thoracoscopic surgical ablation and percutaneous catheter ablation. |
|
| Thoracoscopic surgical ablation group | Active Comparator | Patients in this group will receive only totally thoracoscopic surgical ablation with Fuwai lesion set. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hybrid ablation | Procedure | This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhe Zheng, MD,PhD | Chinese Academy of Medical Sciences, Fuwai Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China National Center for Cardiovascular Diseases | Beijing | Beijing Municipality | 100037 | China |
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| Thoracoscopic surgical ablation | Procedure | This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation. |
|
| 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 |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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