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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
This intervention including thoracoscopic surgical ablation and cardiovascular risk control.
Guangdong General Hospital
Guangzhou, Guangdong, China
RECRUITINGAtrial tachyarrhythmia recurrence
Atrial arrhythmia (including atrial tachycardia, atrial flutter and atrial fibrillation) longer than 30s, off antiarrhythmic therapy, recorded by ECG or Holter.
Time frame: 24 months after blanking-period.
Systemic atrial embolism
Including cerebral infarction and other peripheral atrial embolism
Time frame: 24 months after blanking-period.
Left atrial thrombus
New-onset left atrial thrombus confirmed by TEE or TTE
Time frame: At 3months, 6months, 12months, 18months, 24months after intervention.
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