Laser Ablation Study for trEatment of atRial Fibrillation (LASER) (LASER)

August 1, 2018 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Catalunya
      • Barcelona, Catalunya, Spain, 08028
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Laser ablation
Ablation with laser catheter
Device: Laser ablation
Pulmonary vein isolation using the laser ablation catheter
Other: RF ablation
Ablation with RF catheter
Device: RF ablation
Pulmonary vein isolation using the RF ablation catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Collaborators

CardioFocus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

February 1, 2018

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 20, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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