NCT02504567

Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Laser ablation	Pulmonary vein isolation using the laser ablation catheter
DEVICE	RF ablation	Pulmonary vein isolation using the RF ablation catheter

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-11-01
• Completion: 2018-02-01
• First posted: 2015-07-22
• Last updated: 2018-08-02

Locations

1 site across 1 country: Spain