Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Hospital Clinic of Barcelona1 site in 1 country64 target enrollmentJuly 2015

ConditionsAtrial Fibrillation

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Hospital Clinic of Barcelona
Enrollment: 64
Locations: 1
Primary Endpoint: Presence of large gaps in the delayed enhancement MRI (DE-MRI)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

February 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Clinic of Barcelona

Responsible Party

Principal Investigator

Josep Lluis Mont Girbau

MD Phd

Hospital Clinic of Barcelona

Eligibility Criteria

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

Outcomes

Primary Outcomes

Presence of large gaps in the delayed enhancement MRI (DE-MRI)

Time Frame: 3 months

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.