Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
LASER
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 atrial-fibrillation
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedAugust 2, 2018
August 1, 2018
1.3 years
July 15, 2015
August 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To determine the number of patients that present atrial fibrillation after the ablation procedure
1 year
Study Arms (2)
Laser ablation
OTHERAblation with laser catheter
RF ablation
OTHERAblation with RF catheter
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Clinic of Barcelonalead
- CardioFocuscollaborator
Study Sites (1)
Hospital Clínic de Barcelona
Barcelona, Catalonia, 08028, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD Phd
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 22, 2015
Study Start
July 1, 2015
Primary Completion
November 1, 2016
Study Completion
February 1, 2018
Last Updated
August 2, 2018
Record last verified: 2018-08