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

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Unknown; Phase 2

Conditions: Atrial Fibrillation

Treatments: Device: Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting; Device: Surgical ablation of the left atrium (PVI+Box lesions)

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02562391

9872TLAA

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

PVI+Box lesions

Active Comparator group

Description:

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.

Treatment:

Device: Surgical ablation of the left atrium (PVI+Box lesions)

PVI+Box lesions+LAA cutting

Experimental group

Description:

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.

Treatment:

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