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

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Laser ablation
RF ablation
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Catheter Ablation, Radiofrequency, Laser, Atrial Fibrillation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clínic de Barcelona

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Laser ablation

RF ablation

Arm Description

Ablation with laser catheter

Ablation with RF catheter

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 15, 2015
Last Updated
August 1, 2018
Sponsor
Hospital Clinic of Barcelona
Collaborators
CardioFocus
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1. Study Identification

Unique Protocol Identification Number
NCT02504567
Brief Title
Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
Acronym
LASER
Official Title
Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
Collaborators
CardioFocus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Catheter Ablation, Radiofrequency, Laser, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Laser ablation
Arm Type
Other
Arm Description
Ablation with laser catheter
Arm Title
RF ablation
Arm Type
Other
Arm Description
Ablation with RF catheter
Intervention Type
Device
Intervention Name(s)
Laser ablation
Intervention Description
Pulmonary vein isolation using the laser ablation catheter
Intervention Type
Device
Intervention Name(s)
RF ablation
Intervention Description
Pulmonary vein isolation using the RF ablation catheter
Primary Outcome Measure Information:
Title
Presence of large gaps in the delayed enhancement MRI (DE-MRI)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
To determine the number of patients that present atrial fibrillation after the ablation procedure
Description
The number of patients that present a recurrence in their atrial fibrillation after the ablation procedure during the first year.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08028
Country
Spain

12. IPD Sharing Statement

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Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

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