Persistent Atrial Fibrillation
Conditions
Keywords
Hybrid ablation, Thoracoscope
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.
Interventions
PROCEDUREHybrid ablation
This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.
PROCEDUREThoracoscopic surgical ablation
This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate without any recurrence of AF | At 12-month after intervention | Without detections of AF (episodes longer than 30 seconds) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | preoperative and 12-month after intervention | Measured with questionnaire of AF effect on Quality of Life |
| Adverse events | 12 months follow up | Major adverse cardiovascular events; Major bleeding events; Major thromboembolic events. |
| Burden of AF | At 12-month after intervention | Burden of AF according to Tele-ECG-Card lasting for one week |
| postoperative complications | 30 days after operation | perioperative complication of catheter ablation and thoracoscopic surgical abaltion |
| Survival rate without any recurrence of atrial tachyarrhythmia | At 12-month after intervention | Survival rate without AF, atrial flutter or atrial tachycardia will be defined by absence of any of these electrocardiographically documented events lasting \> 30 seconds. |
| Left atrial function | preoperative and postoperative | left atrial ejection fraction and left atrial expansion index |
Countries
China
Outcome results
None listed