Hybrid Procedure in Patients With Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram, 24 hour Holter monitoring, and 2 week long-term electrocardiogram of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

Detailed Description
-----------------
Atrial fibrillation is highly associated with sudden death and stroke, requiring definitive treatment. In Korea, atrial fibrillation is a common disease predicted to affect more than 5% of the population over 65 years of age and more than 10% over 80 years. Totally thoracoscopic ablation has been adopted and performed successfully on February 2012 at Samsung Medical Center for the first time in Korea. More than 120 operations have been performed up to date. In Korea, treatment for atrial fibrillation is still dependent on percutaneous RFCA, and life-long medication and anticoagulation is needed when recurrent atrial fibrillation occurs. The investigators expected thoracoscopic ablation to be an alternative to overcome this limitation. Also, thoracoscopic ablation and RFCA are recently being performed simultaneously or stage by stage as a hybrid procedure, and the results are being reported. In this study, the investigators therefore comparatively analyzed the mid-term results (at 1 year) including electrocardiogram and 24 hour Holter monitoring of thoracoscopic ablation and RFCA performed individually or as a hybrid procedure in patients with long-lasting persistent atrial fibrillation. Antiarrhythmic medication, discontinuation of anticoagulation medication, and echocardiographic findings were also analyzed.

Official Title
-----------------
Comparison of Success Rate of Totally Thoracoscopic Ablation Versus Hybrid Procedure in Patients With Persistent Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Procedure: Hybrid procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Long-lasting persistent atrial fibrillation Persistent atrial fibrillation refractory to antiarrhythmic drug therapy over 18 years Exclusion Criteria: Valvular heart disease of more than moderate degree Unresponsive ischemic cardiomyopathy Follow-up of over 1 year was not possible Warfarin was unable to be used Refusal of informed consent Left atrial thrombus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Thoracoscopic ablation group<br>Patients who will undergo thoracoscopic ablation only | |
| Active Comparator: Hybrid procedure<br>Patients who will undergo hybrid procedure (thoracoscopic ablation and eletrophyologic study with or without additional ablation) | Procedure: Hybrid procedure<br>* Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium<br>* Other names: Postprocedural electrophysiological study;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac related death | medical records review | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke | medical records review at 3, 6 and 12 months follow up | postoperative one year | 
| Bleeding | medical records review at 3, 6 and 12 months follow up | postoperative one year | 
| Embolism | medical records review at 3, 6 and 12 months follow up | postoperative one year | 
| Recurred atrial arrhythmia | medical records review at 3, 6 and 12 months follow up | postoperative one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation, Ablation, Hybrid