Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation

Study Overview
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Brief Summary
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The purpose of this study is to collect data on laser ballon (2nd gen) systems for catheter ablation for AF, in order to determine the safety and the efficacy of this technique. Moreover, the investigators aim to determine the short and long term outcomes of pulmonary vein isolation evaluating arrhythmia recurrence, especially using continuous rhythm monitoring with implantable loop recorders (ILR).

Detailed Description
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LIGHT-AF is an observational, multicentric study designed to collect pre-procedural, procedural and follow-up data of consecutive patients that underwent catheter ablation for AF with laser ballon (2nd gen system). A number of 3 enrolling centers is estimated with an overall number of about 100 patients. A minimal follow-up of 3 months is required before analyzing clinical outcomes. The data analysis will focus on implant outcomes and early, mid and long-term recurrence of AF, evaluated with intracardiac rhythm monitoring.

Official Title
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Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation Assessed by Continuous Rhythm Monitoring

Conditions
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Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent

Intervention / Treatment
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* Procedure: Catheter Ablation for AF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >/= 18 years Patients with paroxysmal, persistent or long-standing persistent AF Patients able to provide written informed consent or have informed consent as provided by a legal representative Exclusion Criteria: Age < 18 years Patients unable or unwilling to receive oral anticoagulation

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Catheter Ablation for AF|Pulmonary vein isolation (PVI) is the mainstay goal of atrial fibrillation (AF) ablation procedures, especially in paroxysmal AF (PAF), and is recommended during all AF ablation procedures. PVI can be obtained with different techniques, using 3D-mapping systems guiding point-by-point radiofrequency (RF) ablation procedures or balloon-based ablation systems (cryo- or laser balloon), introduced to simplify catheter ablation for AF. In particular, the 2nd generation of visually guided laser balloon ablation system (LB2) makes use of laser energy to achieve PVI, leading to better PV occlusion and isolation compared to the 1st generation.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AF recurrences | Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arrhythmia burden | Percentage of overall time in AF | 2 years | 
| Redo ablation procedures | Patients requiring a redo ablation procedure, after the first one | 2 years | 
| Adverse events | Procedural mortality or other adverse events related to the procedure | 2 years |