Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Device: Laser ablation; Device: RF ablation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02504567

Laser

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Laser ablation

Other group

Description:

Ablation with laser catheter

Treatment:

Device: Laser ablation

RF ablation

Other group

Description:

Ablation with RF catheter

Treatment:

Device: RF ablation