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

Phase 2

• Conditions: Atrial Fibrillation
• Interventions: 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)

• Registration Number: NCT02562391
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05
• Primary Completion: 2015-05
• Status Verified: 2015-09
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-25
• Last Update Submitted: 2015-09-25
• Study First Posted: 2015-09-29
• Last Update Posted: 2015-09-29
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PVI+Box lesions+LAA cutting	Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting	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.
PVI+Box lesions	Surgical ablation of the left atrium (PVI+Box lesions)	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.

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation recurrences	18 months

Trial Locations

Locations (4)

Federal Center of Cardiovascular surgery; 🇷🇺 Krasnoyarsk, Russian Federation

Federal State Institution Clinical Hospital of the Presidental Administration of the RF; 🇷🇺 Moscow, Russian Federation

Scientific center of the cardiovascular surgery named by A.N. Bakulev; 🇷🇺 Moscow, Russian Federation

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation