Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Study Overview
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Brief Summary
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This protocol aims at assessing the efficacy of performing catheter ablation for atrial fibrillation (AF) with laser catheters versus performing it with radiofrequency (RF) catheters. In order to study laser catheter ablation efficacy, MRI analysis of the lesions 3 months after the procedure will be performed in both groups. MRI analysis will detect ablation gaps in the lesions encircling pulmonary veins. The primary endpoint will compare the number of gaps in the laser catheter and the RF group. The secondary endpoint of the study is recurrence of AF after 12 months. The target population of the study is patients with paroxysmal or persistent AF undergoing AF ablation.

Official Title
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Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Device: Laser ablation
* Device: RF ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with clinical recurrent AF, refractary or intolerant to at least 1 antiarrhythmic drub who are scheduled to undergo ablation of pulmonary veins (PV) Signed consent form. Exclusion Criteria: Being under 18 years old Any contraindication for ablation procedure Impossibility to acquire DE-MRI because of contraindication (e.g. severely impaired renal function) or patient unwillingness

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Laser ablation<br>Ablation with laser catheter | Device: Laser ablation<br>* Pulmonary vein isolation using the laser ablation catheter<br>|
| Other: RF ablation<br>Ablation with RF catheter | Device: RF ablation<br>* Pulmonary vein isolation using the RF ablation catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of large gaps in the delayed enhancement MRI (DE-MRI) | The presence of MRI ablation gaps around the pulmonary veins evaluated with MRI images of the patient acquired three months after the ablation procedure. A large gap is described as a GAP that is larger or equal than 20% of the vein perimeter. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the number of patients that present atrial fibrillation after the ablation procedure | The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter Ablation, Radiofrequency, Laser, Atrial Fibrillation