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

September 9, 2020 updated by: Giovanni B Forleo, Luigi Sacco University Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Monza, Italy, 20900
        • Ospedale San Gerardo - Asst Monza
    • Mi
      • Milan, Mi, Italy, 20174
        • Ospedale Luigi Sacco - Polo Universitario
    • Milano
      • San Donato Milanese, Milano, Italy, 20097
        • IRCCS Policlinico San Donato

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients >/= 18 years, with paroxysmal or persistent AF, that met the indications provided by international guidelines to undergo catheter ablation for AF as standard of care.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AF recurrences
Time Frame: 2 years
Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias
2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luigi Sacco University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 28, 2018

Primary Completion (ANTICIPATED)

December 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

September 2, 2020

First Submitted That Met QC Criteria

September 9, 2020

First Posted (ACTUAL)

September 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 10, 2020

Last Update Submitted That Met QC Criteria

September 9, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIGHT-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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