Atrial Fibrillation Clinical Trial
— LIGHT-AFOfficial title:
Outcomes of Second Generation Laser Balloon Ablation for Atrial Fibrillation Assessed by Continuous Rhythm Monitoring
Verified date | September 2020 |
Source | Luigi Sacco University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Luigi Sacco University Hospital |
Italy,
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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