Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Phase 4

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Laser ablation; Device: RF ablation

• Registration Number: NCT02504567
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-22
• Primary Completion: 2016-11
• Study Completion: 2018-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-01
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laser ablation	Laser ablation	Ablation with laser catheter
RF ablation	RF ablation	Ablation with RF catheter

Primary Outcome Measures

Name	Time	Method
Presence of large gaps in the delayed enhancement MRI (DE-MRI)	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.

Secondary Outcome Measures

Name	Time	Method
To determine the number of patients that present atrial fibrillation after the ablation procedure	1 year	The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year.

Trial Locations

Locations (1)

Hospital Clínic de Barcelona; 🇪🇸 Barcelona, Catalunya, Spain