Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
LIGHT-AF
1 other identifier
observational
100
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2018
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2018
CompletedFirst Submitted
Initial submission to the registry
September 2, 2020
CompletedFirst Posted
Study publicly available on registry
September 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedSeptember 10, 2020
September 1, 2020
4.2 years
September 2, 2020
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
AF recurrences
Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias
2 years
Secondary Outcomes (3)
Arrhythmia burden
2 years
Redo ablation procedures
2 years
Adverse events
2 years
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
- Patients unable or unwilling to receive oral anticoagulation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097, Italy
Ospedale Luigi Sacco - Polo Universitario
Milan, Mi, 20174, Italy
Ospedale San Gerardo - ASST Monza
Monza, 20900, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Section Head Electrophysiology
Study Record Dates
First Submitted
September 2, 2020
First Posted
September 10, 2020
Study Start
September 28, 2018
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
September 10, 2020
Record last verified: 2020-09