Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation (LIGHT-AF)

Luigi Sacco University Hospital

Status: Unknown

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

Treatments: Procedure: Catheter Ablation for AF

Study type: Observational

Funder types: Other

Identifiers

NCT04544397

LIGHT-AF

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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