NCT04544397

Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Luigi Sacco University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Atrial Fibrillation
• Atrial Fibrillation Paroxysmal
• Atrial Fibrillation, Persistent

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-09-28
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2020-09-10
• Last updated: 2020-09-10

Locations

3 sites across 1 country: Italy