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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04544397
Recruitment Status : Active, not recruiting
First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Information provided by (Responsible Party):
Giovanni B Forleo, Luigi Sacco University Hospital

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).


Condition or disease Intervention/treatment
Atrial Fibrillation Atrial Fibrillation Paroxysmal Atrial Fibrillation, Persistent Procedure: Catheter Ablation for AF

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 2 Years
Official Title: Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation Assessed by Continuous Rhythm Monitoring
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. AF recurrences [ Time Frame: 2 years ]
    Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias


Secondary Outcome Measures :
  1. Arrhythmia burden [ Time Frame: 2 years ]
    Percentage of overall time in AF

  2. Redo ablation procedures [ Time Frame: 2 years ]
    Patients requiring a redo ablation procedure, after the first one

  3. Adverse events [ Time Frame: 2 years ]
    Procedural mortality or other adverse events related to the procedure


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04544397


Locations
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Italy
IRCCS Policlinico San Donato
San Donato Milanese, Milano, Italy, 20097
Ospedale Luigi Sacco - Polo Universitario
Milan, Mi, Italy, 20174
Ospedale San Gerardo - ASST Monza
Monza, Italy, 20900
Sponsors and Collaborators
Luigi Sacco University Hospital
More Information
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Responsible Party: Giovanni B Forleo, Section Head Electrophysiology, Luigi Sacco University Hospital
ClinicalTrials.gov Identifier: NCT04544397    
Other Study ID Numbers: LIGHT-AF
First Posted: September 10, 2020    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes