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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04544397
Other study ID # LIGHT-AF
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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