Effect of Left Atrial Appendage Excision on Procedure Outcome in Patients With Persistent and Long-standing Persistent Atrial Fibrillation Undergoing Surgical Ablation

Study Overview
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Brief Summary
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The aim of this study is to assess the effect of left atrial appendage excision on atrial fibrillation recurrence and incidence of stroke in patients with persistent and long-standing persistent atrial fibrillation undergoing surgical ablation.

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Surgical ablation of the left atrium (PVI+Box lesions)
* Device: Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patients with persistent and long-standing persistent atrial fibrillation eligible for thoracoscopy surgical ablation Signed inform consent Key Exclusion Criteria: Paroxysmal atrial fibrillation Contraindications for surgical ablation Unwilling to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI+Box lesions<br>Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. 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. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box. | Device: Surgical ablation of the left atrium (PVI+Box lesions)<br> <br> |
| Experimental: PVI+Box lesions+LAA cutting<br>Patients were treated with video-assisted thoracoscopy under general anesthesia, according to a previously described protocol. In brief, PVI was performed from the epicardial side with a bipolar radiofrequency ablation clamp. 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. In addition to PVI, the bilateral epicardial ganglia were found by high-frequency stimulation and ablated, as confirmed by the absence of a vagal response after ablation. Finally additional lines were made to create a posterior box lesion. Sensing and pacing maneuvers verified isolation of the posterior box.The left atrial appendage was removed by stapling and then cutting. | Device: Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation recurrences |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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atrial fibrillation, ablation, thoracoscopy, left atrial appendage