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Completed

NCT Number: NCT02504567

Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clínic de Barcelona

Barcelona, Catalonia, 08028, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser ablation

Device

Pulmonary vein isolation using the laser ablation catheter

RF ablation

Device

Pulmonary vein isolation using the RF ablation catheter

Primary outcomes

  1. 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.

Secondary outcomes

  1. To determine the number of patients that present atrial fibrillation after the ablation procedure

    Time frame: 1 year

    The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • CardioFocus

Registry information

Acronym: LASER

Important dates

Study start
2015
Primary completion
2016
Study completion
2018
First posted
Jul 22, 2015
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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