Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation

• Conditions: Atrial Fibrillation; Atrial Fibrillation, Persistent; Atrial Fibrillation Paroxysmal

• Registration Number: NCT04544397
• Lead Sponsor: Luigi Sacco University Hospital

Brief 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.

Study Timeline

• Study Start: 2018-09-28
• Status Verified: 2020-09
• Study First Submitted: 2020-09-02
• Study First Submitted QC: 2020-09-09
• Last Update Submitted: 2020-09-09
• Study First Posted: 2020-09-10
• Last Update Posted: 2020-09-10
• Primary Completion: 2022-12-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AF recurrences	2 years	Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias

Secondary Outcome Measures

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

Trial Locations

Locations (3)

IRCCS Policlinico San Donato; 🇮🇹 San Donato Milanese, Milano, Italy

Ospedale Luigi Sacco - Polo Universitario; 🇮🇹 Milan, Mi, Italy

Ospedale San Gerardo - ASST Monza; 🇮🇹 Monza, Italy