Atrial FibrillationLIGHT-AFNCT04544397
Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation
An observational study of Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Luigi Sacco University Hospital at 3 sites in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation Paroxysmal, Atrial Fibrillation, Persistent
- What is being tested?
- Catheter Ablation for AF
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesItaly
- Study dates
- 28 Sep 2018to 1 Dec 2022
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Patients unable or unwilling to receive oral anticoagulation
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale Luigi Sacco - Polo Universitario
Milan, Mi, 20174
Ospedale San Gerardo - ASST Monza
Monza, 20900
IRCCS Policlinico San Donato
San Donato Milanese, Milano, 20097
About this study
Official title: 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).
Read the 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.
- Being tested
- Catheter Ablation for AF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation for AFProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
AF recurrences
Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias
Measured: 2 years
Secondary outcomes (3)
Arrhythmia burden
Percentage of overall time in AF
Measured: 2 years
Redo ablation procedures
Patients requiring a redo ablation procedure, after the first one
Measured: 2 years
Adverse events
Procedural mortality or other adverse events related to the procedure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2020
- Study start28 Sep 2018
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Luigi Sacco University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni B Forleo, Luigi Sacco University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04544397
- Sponsor's protocol ID
- LIGHT-AF
- Acronym
- LIGHT-AF
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 10 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation Assessed by Continuous Rhythm Monitoring
- ClinicalTrials.gov ID
- NCT04544397
- Acronym / sponsor ID
- LIGHT-AF / LIGHT-AF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Luigi Sacco University HospitalUniversity, hospital or other
- Study start
- 28 Sep 2018 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 10 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age < 18 years
- Patients unable or unwilling to receive oral anticoagulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Catheter Ablation for AFPulmonary 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. | Procedure or surgery | – |
Primary outcome
AF recurrences
Time frame: 2 years
Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmias
3 secondary outcomes
Arrhythmia burden
Time frame: 2 years
Redo ablation procedures
Time frame: 2 years
Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Atrial Fibrillation Paroxysmal, run by Luigi Sacco University Hospital at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AF recurrences (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2020.