Laser Ablation Study for trEatment of atRial Fibrillation (LASER)

• Sponsor: Hospital Clinic of Barcelona (Other)
• Overall Status: Completed
• CT.gov ID: NCT02504567
• Collaborator: CardioFocus (Industry)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 31.1
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: Laser ablation; Device: RF ablation	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Laser Ablation Study for trEatment of atRial Fibrillation (LASER)
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 1, 2016
• Actual Study Completion Date: Feb 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Presence of large gaps in the delayed enhancement MRI (DE-MRI) [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 Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clínic de Barcelona	Barcelona	Catalunya	Spain	08028

Sponsors and Collaborators

• Hospital Clinic of Barcelona
• CardioFocus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Josep Lluis Mont Girbau, MD Phd, Hospital Clinic of Barcelona
• ClinicalTrials.gov Identifier: NCT02504567
• Other Study ID Numbers: Laser
• First Posted: Jul 22, 2015
• Last Update Posted: Aug 2, 2018
• Last Verified: Aug 1, 2018

• Keywords provided by Josep Lluis Mont Girbau, MD Phd, Hospital Clinic of Barcelona: Catheter Ablation; Radiofrequency; Laser; Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

No Results Posted as of Aug 2, 2018