Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Atrial Fibrillation Clinical Trial

— LASER  

Official title:

Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02504567
• Other study ID #: Laser
• Status: Completed
• Phase: Phase 4
• Start date: July 2015
• Est. completion date: February 2018

Study information

• Verified date: August 2018
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Laser ablation
Pulmonary vein isolation using the laser ablation catheter
• RF ablation
Pulmonary vein isolation using the RF ablation catheter

Locations

Country	Name	City	State
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona	CardioFocus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of large gaps in the delayed enhancement MRI (DE-MRI)	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.	3 months
Secondary	To determine the number of patients that present atrial fibrillation after the ablation procedure	The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year.	1 year