Thoracoscopic Versus Endocardial Ablation in Patient With Paroxysmal AF After Failed Initial Endocardial Ablation

Study Overview
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Brief Summary
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The investigators aimed to compare two approaches thoracoscopic epicardial ablation and endocardial catheter ablation after failed initial catheter ablation in patients with paroxysmal atrial fibrillation.

Official Title
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Thoracoscopic Ablation Versus Endocardial Ablation in Patient With Paroxysmal Atrial Fibrillation After Failed Initial Endocardial Ablation

Conditions
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Paroxysmal Atrial Fibrillation

Intervention / Treatment
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* Procedure: Thoracoscopic epicardial ablation
* Procedure: Endocardial catheter ablation
* Device: Implantable loop recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: failed initial catheter ablation paroxysmal atrial fibrillation Exclusion Criteria: chronic lung disease body mass index >35 longstanding atrial fibrillation 1 year previous stroke or transient ischemic attack left atrial thrombus left atrial size >65 mm left ventricular ejection fraction <35%

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thoracoscopic epicardial ablation<br>Patients were treated with video-assisted thoracoscopy under general anesthesia. PVI was performed from the epicardial side with a bipolar RF ablation clamp (AtriCure). At least 2 overlapping applications around each of the ipsilateral veins were made, and isolation was confirmed by the absence of PV potentials and exit block during pacing. An additional application was made in the interatrial Waterston groove in the right side to isolate the ganglionic plexi from the atria. On the left side, the ligament of Marshal was cut, but no additional ablation of ganglionic plexi was pursued. The RevealXT (implantable loop recorder) was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check. | Procedure: Thoracoscopic epicardial ablation<br> <br> Device: Implantable loop recorder<br> <br> |
| Active Comparator: Endocardial catheter ablation<br>Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a ﬂow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster). The RevealXT (implantable loop recorder) was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check. | Procedure: Endocardial catheter ablation<br> <br> Device: Implantable loop recorder<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| freedom from any atrial arrhythmia |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of significant adverse events (SAEs) |  | 12 months | 
| atrial fibrillation burden by ILR |  | 12 months |