Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— LIGHT-AF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04544397
• Other study ID #: LIGHT-AF
• Status: Active, not recruiting
• Start date: September 28, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: September 2020
• Source: Luigi Sacco University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Italy	Ospedale Luigi Sacco - Polo Universitario	Milan	Mi
Italy	Ospedale San Gerardo - ASST Monza	Monza
Italy	IRCCS Policlinico San Donato	San Donato Milanese	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Luigi Sacco University Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AF recurrences	Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias	2 years
Secondary	Arrhythmia burden	Percentage of overall time in AF	2 years
Secondary	Redo ablation procedures	Patients requiring a redo ablation procedure, after the first one	2 years
Secondary	Adverse events	Procedural mortality or other adverse events related to the procedure	2 years