Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02504567

Acronym

LASER

Enrollment

Registered

2015-07-22

Start date

2015-07-31

Completion date

2018-02-28

Last updated

2018-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Catheter Ablation, Radiofrequency, Laser, Atrial Fibrillation

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.

Interventions

DEVICELaser ablation

Pulmonary vein isolation using the laser ablation catheter

DEVICERF ablation

Pulmonary vein isolation using the RF ablation catheter

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026